CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
This device is manufactured by ABBOTT, ABBOTT MEDICAL, ABBOTT VASCULAR, BOSTON SCIENTIFIC CORPORATION, BOSTON SCIENTIFIC IRELAND LIMITED, ST JUDE MED - NEUROMODULATION, ST JUDE MEDICAL, ST JUDE MEDICAL - NEUROMODULATION.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2024-07-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-08 | Injury | Air Embolism | None |
| 2024-07-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-07-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-06-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-06-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Entrapment of Device |
| 2024-06-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-06-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-06-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-06-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-06-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-06-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-06-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Entrapment of Device |
| 2024-06-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-06-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-06-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Entrapment of Device |
| 2024-06-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture, Failure to Advance |
| 2024-06-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-06-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-06-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-05-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-05-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-05-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component |
| 2024-05-29 | Injury | Shock, Vascular Dissection, Pericardial Effusion | Material Rupture |
| 2024-05-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-05-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-05-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-05-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-05-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture, Adverse Event Without Identified Device or Use Problem |
| 2024-05-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-05-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-05-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-05-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-05-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-05-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-05-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-05-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-05-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-05-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Leak/Splash, Material Deformation |
| 2024-05-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break, Failure to Advance |
| 2024-04-25 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-04-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-04-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component, Adverse Event Without Identified Device or Use Problem |
| 2024-04-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-04-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-04-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-04-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Contamination |
| 2024-04-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture, Material Integrity Problem |
| 2024-04-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-04-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-04-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-04-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-04-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break, Difficult to Remove, Adverse Event Without Identified Device or Use Problem |
| 2024-04-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-04-10 | Death | Hemorrhage/Blood Loss/Bleeding, Perforation, Vascular Dissection | Failure to Advance |
| 2024-04-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-04-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Integrity Problem |
| 2024-04-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-04-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-04-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-04-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-04-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-04-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-04-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-04-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-03-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-03-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Integrity Problem |
| 2024-03-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Remove, Material Twisted/Bent |
| 2024-03-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation, Material Integrity Problem |
| 2024-03-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Contamination, Device Contaminated During Manufacture or Shipping |
| 2024-02-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-02-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance, Adverse Event Without Identified Device or Use Problem |
| 2024-02-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-02-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-02-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-02-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-02-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-02-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance |
| 2024-02-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-02-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture, Failure to Advance |
| 2024-02-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-02-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-02-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-02-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-02-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-02-15 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Remove, Adverse Event Without Identified Device or Use Problem |
| 2024-02-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-02-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-02-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-02-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-02-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-02-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break, Material Deformation |
| 2024-02-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture, Failure to Advance |
| 2024-02-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-02-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-02-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-02-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-01-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Entrapment of Device, Material Deformation |
| 2024-01-24 | Malfunction | Failure of Implant | None |
| 2024-01-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-01-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-01-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-01-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-01-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-01-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-01-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-01-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Entrapment of Device |
| 2024-01-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-01-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-01-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-01-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-01-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-01-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-01-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2024-01-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-01-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Entrapment of Device |
| 2023-12-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component |
| 2023-12-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-12-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-12-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-12-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-12-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-12-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Entrapment of Device |
| 2023-12-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component |
| 2023-12-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance, Adverse Event Without Identified Device or Use Problem |
| 2023-11-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Leak/Splash |
| 2023-11-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-11-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-10-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-10-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-10-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-10-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Leak/Splash |
| 2023-10-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-10-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Inflation Problem, Material Rupture |
| 2023-10-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-10-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-10-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-10-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-10-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-10-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-10-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-09-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Device, Detachment of Device or Device Component |
| 2023-09-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Entrapment of Device |
| 2023-09-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-09-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-09-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture, Failure to Advance |
| 2023-09-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-09-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-09-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-09-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance, Detachment of Device or Device Component |
| 2023-09-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-09-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-09-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break, Material Deformation |
| 2023-09-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-09-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-09-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-09-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-09-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-08-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-08-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-08-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-08-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Entrapment of Device |
| 2023-08-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-08-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Remove, Material Deformation |
| 2023-08-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-08-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-08-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2023-08-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-08-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-08-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-08-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-08-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-08-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-08-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-08-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-08-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-08-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance |
| 2023-08-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Leak/Splash, Material Rupture |
| 2023-08-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-07-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-07-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-07-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Contamination, Defective Device |
| 2023-07-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Entrapment of Device, Defective Device, Material Integrity Problem |
| 2023-07-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Inflation Problem, Leak/Splash, Material Integrity Problem |
| 2023-07-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-07-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-07-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2023-07-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break |
| 2023-07-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-07-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-07-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-07-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Entrapment of Device |
| 2023-06-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-06-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-06-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-06-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-06-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-06-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-06-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-06-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-06-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-06-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture, Failure to Advance |
| 2023-06-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-06-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture, Difficult to Advance |
| 2023-06-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-06-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-05-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Leak/Splash, Material Integrity Problem |
| 2023-05-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-05-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-05-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-05-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-05-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2023-05-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-04-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-04-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Advance |
| 2023-04-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component, Material Deformation |
| 2023-04-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-04-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture, Adverse Event Without Identified Device or Use Problem |
| 2023-04-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-04-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-04-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Entrapment of Device |
| 2023-04-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Puncture/Hole |
| 2023-04-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture, Device-Device Incompatibility |
| 2023-03-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-03-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-03-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-03-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-03-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-03-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-03-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-03-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Entrapment of Device |
| 2023-03-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-03-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-02-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-02-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-02-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-02-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-02-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-02-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-02-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Contamination, Difficult to Open or Remove Packaging Material |
| 2023-01-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Leak/Splash |
| 2023-01-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-01-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-01-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Leak/Splash |
| 2023-01-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2023-01-10 | Injury | Foreign Body In Patient, No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component |
| 2023-01-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2022-12-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Advance |
| 2022-12-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2022-12-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2022-12-22 | Malfunction | None | Material Rupture |
| 2022-12-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2022-12-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2022-12-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2022-12-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2022-12-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2022-12-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2022-12-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2022-12-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2022-12-12 | Malfunction | None | Material Rupture |
| 2022-12-12 | Malfunction | None | Material Rupture |
| 2022-12-08 | Malfunction | None | Material Rupture |
| 2022-12-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2022-12-07 | Malfunction | None | Material Rupture |
| 2022-12-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Inflation Problem |
| 2022-12-04 | Malfunction | None | Material Rupture |
| 2022-12-02 | Malfunction | None | Material Rupture |
| 2022-12-02 | Malfunction | None | Material Rupture |
| 2022-11-11 | Malfunction | None | Material Rupture |
| 2022-11-11 | Malfunction | None | Material Rupture |
| 2022-11-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Remove, Detachment of Device or Device Component |
| 2022-11-04 | Malfunction | None | Material Rupture |
| 2022-11-01 | Malfunction | None | Material Rupture |
| 2022-10-29 | Malfunction | None | Break, Difficult to Advance |
| 2022-10-27 | Malfunction | None | Material Rupture |
| 2022-10-27 | Malfunction | None | Material Rupture |
| 2022-10-27 | Malfunction | None | Material Rupture |
| 2022-10-25 | Malfunction | None | Material Rupture |
| 2022-10-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2022-10-24 | Malfunction | None | Material Rupture |
| 2022-10-21 | Malfunction | None | Material Rupture |
| 2022-10-21 | Malfunction | None | Material Rupture |
| 2022-10-20 | Malfunction | None | Material Rupture |
| 2022-10-20 | Malfunction | None | Material Rupture |
| 2022-10-19 | Malfunction | None | Material Rupture |
| 2022-10-19 | Malfunction | None | Material Rupture |
| 2022-10-18 | Malfunction | None | Material Rupture |
| 2022-10-13 | Malfunction | None | Material Rupture |
| 2022-10-12 | Malfunction | None | Entrapment of Device |
| 2022-10-11 | Malfunction | None | Material Rupture |
| 2022-10-11 | Malfunction | None | Break, Failure to Advance |
| 2022-10-07 | Malfunction | None | Material Rupture |
| 2022-10-06 | Injury | None | Detachment of Device or Device Component |
| 2022-10-05 | Malfunction | None | Material Rupture |
| 2022-10-03 | Malfunction | None | Material Rupture |
| 2022-09-28 | Malfunction | None | Material Rupture |
| 2022-09-26 | Malfunction | None | Material Rupture |
| 2022-09-21 | Malfunction | None | Material Rupture |
| 2022-09-15 | Malfunction | None | Material Rupture |
| 2022-09-09 | Malfunction | None | Material Rupture |
| 2022-09-09 | Malfunction | None | Material Rupture |
| 2022-09-09 | Malfunction | None | Entrapment of Device |
| 2022-09-06 | Malfunction | None | Material Rupture |
| 2022-09-02 | Malfunction | None | Material Rupture |
| 2022-09-01 | Malfunction | None | Material Rupture |
| 2022-08-30 | Malfunction | None | Material Rupture, Failure to Advance |
| 2022-08-23 | Malfunction | None | Material Rupture |
| 2022-08-23 | Malfunction | None | Material Rupture |
| 2022-08-22 | Malfunction | None | Material Rupture |
| 2022-08-21 | Malfunction | None | Material Rupture |
| 2022-08-19 | Malfunction | None | Inflation Problem, Material Rupture |
| 2022-08-16 | Malfunction | None | Break, Detachment of Device or Device Component |
| 2022-08-16 | Malfunction | None | Material Rupture |
| 2022-08-11 | Malfunction | None | Material Deformation |
| 2022-08-09 | Malfunction | None | Material Rupture |
| 2022-08-09 | Malfunction | None | Failure to Advance |
| 2022-08-05 | Malfunction | None | Break |
| 2022-08-03 | Malfunction | None | Break |
| 2022-08-01 | Malfunction | None | Material Rupture |
| 2022-07-28 | Malfunction | None | Leak/Splash |
| 2022-07-27 | Malfunction | None | Break |
| 2022-07-26 | Malfunction | None | Break |
| 2022-07-19 | Malfunction | None | Break, Material Deformation |
| 2022-07-18 | Malfunction | None | Material Rupture |
| 2022-07-11 | Malfunction | None | Difficult to Remove, Detachment of Device or Device Component |
| 2022-07-01 | Malfunction | None | Material Rupture, Material Integrity Problem |
| 2022-07-01 | Malfunction | None | Material Rupture |
| 2022-07-01 | Malfunction | None | Material Rupture |
| 2022-06-29 | Malfunction | None | Material Rupture |
| 2022-06-29 | Malfunction | None | Material Rupture |
| 2022-06-28 | Malfunction | None | Material Rupture |
| 2022-04-14 | Malfunction | None | Difficult to Advance, Material Deformation |
| 2022-04-13 | Malfunction | None | Material Rupture |
| 2022-04-12 | Malfunction | None | Material Rupture |
| 2022-04-11 | Malfunction | None | Entrapment of Device, Material Integrity Problem |
| 2022-04-11 | Malfunction | None | Material Rupture |
| 2022-04-08 | Malfunction | None | Material Rupture |
| 2022-04-07 | Malfunction | None | Material Rupture |
| 2022-04-01 | Malfunction | None | Difficult to Remove |
| 2022-03-31 | Malfunction | None | Material Rupture |
| 2022-03-25 | Malfunction | None | Material Rupture |
| 2022-03-25 | Malfunction | None | Material Rupture |
| 2022-03-23 | Malfunction | None | Failure to Advance |
| 2022-03-22 | Malfunction | None | Material Rupture |
| 2022-03-21 | Malfunction | None | Material Rupture |
| 2022-03-18 | Malfunction | None | Material Rupture |
| 2022-03-18 | Malfunction | None | Material Rupture |
| 2022-03-16 | Malfunction | None | Break |
| 2022-03-15 | Malfunction | None | Material Rupture |
| 2022-03-14 | Malfunction | None | Material Rupture |
| 2022-03-13 | Malfunction | None | Material Puncture/Hole |
| 2022-03-10 | Malfunction | None | Material Rupture |
| 2022-03-10 | Malfunction | None | Material Rupture |
| 2022-03-10 | Malfunction | None | Material Rupture |
| 2022-03-09 | Malfunction | None | Material Rupture, Device Dislodged or Dislocated |
| 2022-03-08 | Malfunction | None | Material Rupture |
| 2022-03-06 | Malfunction | None | Material Rupture |
| 2022-03-03 | Malfunction | None | Material Rupture |
| 2022-01-04 | Malfunction | None | Failure to Advance |
| 2019-09-04 | Malfunction | None | Material Rupture |
| 2019-09-03 | Malfunction | None | Material Rupture |
| 2019-09-03 | Malfunction | None | Material Rupture |
| 2019-09-01 | Malfunction | None | Material Rupture |
| 2019-09-01 | Malfunction | None | Device Dislodged or Dislocated |
| 2019-08-29 | Malfunction | None | Material Rupture |
| 2019-08-29 | Malfunction | None | Material Rupture |
| 2019-08-28 | Malfunction | None | Material Rupture |
| 2019-08-27 | Malfunction | None | Material Rupture |
| 2019-08-26 | Malfunction | None | Material Rupture |
| 2019-08-23 | Malfunction | None | Material Rupture |
| 2019-08-22 | Malfunction | None | Device-Device Incompatibility, Material Deformation |
| 2019-08-20 | Malfunction | None | Material Rupture |
| 2019-08-20 | Malfunction | None | Material Rupture |
| 2019-08-19 | Injury | None | Material Rupture |
| 2019-08-16 | Malfunction | None | Material Rupture |
| 2019-08-16 | Malfunction | None | Contamination |
| 2019-08-16 | Malfunction | None | Material Rupture |
| 2019-08-15 | Malfunction | None | Material Rupture |
| 2019-08-14 | Malfunction | None | Material Rupture |
| 2019-08-14 | Malfunction | None | Material Rupture |
| 2019-08-09 | Malfunction | None | Material Rupture |
| 2019-08-09 | Malfunction | None | Material Rupture |
| 2019-08-08 | Malfunction | None | Material Rupture |
| 2019-08-07 | Malfunction | None | Material Rupture, Difficult to Advance |
| 2019-08-07 | Malfunction | None | Material Rupture |
| 2019-08-05 | Malfunction | None | Material Rupture |
| 2019-08-02 | Malfunction | None | Material Rupture |
| 2019-08-01 | Malfunction | None | Material Rupture |
| 2019-08-01 | Malfunction | None | Material Rupture |
| 2019-08-01 | Malfunction | None | Material Rupture |
| 2019-07-31 | Malfunction | None | Material Rupture |
| 2019-07-29 | Malfunction | None | Material Rupture |
| 2019-07-23 | Malfunction | None | Material Rupture |
| 2019-07-23 | Malfunction | None | Material Rupture |
| 2019-07-22 | Malfunction | None | Material Rupture |
| 2019-07-20 | Malfunction | None | Material Rupture |
| 2019-07-20 | Malfunction | None | Material Rupture |
| 2019-07-16 | Malfunction | None | Material Rupture |
| 2019-07-16 | Malfunction | None | Material Rupture |
| 2019-07-12 | Malfunction | None | Break, Physical Resistance/Sticking |
| 2019-07-10 | Malfunction | None | Material Rupture |
| 2019-07-10 | Malfunction | None | Material Rupture |
| 2019-07-10 | Malfunction | None | Material Rupture |
| 2019-07-09 | Malfunction | None | Material Rupture |
| 2019-07-03 | Malfunction | None | Material Rupture |
| 2019-07-01 | Injury | None | Material Rupture |
| 2019-06-26 | Malfunction | None | Difficult to Insert, Leak/Splash |
| 2019-06-25 | Malfunction | None | Material Rupture |
| 2019-06-23 | Malfunction | None | Material Rupture |
| 2019-06-21 | Malfunction | None | Material Rupture |
| 2019-06-20 | Malfunction | None | Material Rupture |
| 2019-06-20 | Malfunction | None | Material Rupture |
| 2019-06-19 | Malfunction | None | Defective Device |
| 2019-06-18 | Malfunction | None | Material Rupture |
| 2019-06-18 | Malfunction | None | Material Rupture |
| 2019-06-17 | Malfunction | None | Material Rupture |
| 2019-06-14 | Malfunction | None | Material Rupture |
| 2019-06-14 | Malfunction | None | Difficult to Remove, Material Deformation |
| 2019-06-11 | Malfunction | None | Material Rupture |
| 2019-06-11 | Malfunction | None | Material Rupture |
| 2019-06-04 | Malfunction | None | Material Rupture |
| 2019-06-04 | Malfunction | None | Material Rupture |
| 2019-06-04 | Malfunction | None | Material Rupture |
| 2019-06-03 | Malfunction | None | Material Rupture |
| 2019-06-03 | Malfunction | None | Material Rupture |
| 2019-06-03 | Malfunction | None | Material Rupture |
| 2019-05-30 | Malfunction | None | Difficult to Remove, Material Deformation |
| 2019-05-30 | Injury | None | Material Rupture |
| 2019-05-30 | Malfunction | None | Material Rupture |
| 2019-05-29 | Malfunction | None | Failure to Advance |
| 2019-05-29 | Malfunction | None | Material Rupture |
| 2019-05-28 | Malfunction | None | Material Rupture |
| 2019-05-28 | Malfunction | None | Material Rupture |
| 2019-05-24 | Malfunction | None | Material Rupture |
| 2019-05-23 | Malfunction | None | Material Rupture |
| 2019-05-23 | Malfunction | None | Material Rupture |
| 2019-05-23 | Malfunction | None | Material Rupture |
| 2019-05-23 | Malfunction | None | Material Rupture |
| 2019-05-23 | Malfunction | None | Material Rupture |
| 2019-05-22 | Malfunction | None | Material Rupture |
| 2019-05-21 | Malfunction | None | Material Rupture |
| 2019-05-21 | Malfunction | None | Material Rupture |
| 2019-05-14 | Malfunction | None | Material Rupture |
| 2019-05-13 | Malfunction | None | Material Rupture |
| 2019-05-10 | Malfunction | None | Material Rupture, Failure to Advance |
| 2019-05-09 | Malfunction | None | Material Rupture |
| 2019-05-08 | Malfunction | None | Break |
| 2019-05-07 | Malfunction | None | Material Rupture |
| 2019-05-07 | Malfunction | None | Material Rupture |
| 2019-05-07 | Malfunction | None | Material Rupture |
| 2019-05-02 | Injury | None | Break |
| 2019-04-26 | Malfunction | None | Material Rupture |
| 2019-04-26 | Malfunction | None | Material Rupture |
| 2019-04-25 | Malfunction | None | Material Rupture |
| 2019-04-24 | Malfunction | None | Material Rupture |
| 2019-04-23 | Malfunction | None | Material Rupture |
| 2019-04-23 | Malfunction | None | Material Rupture |
| 2019-04-23 | Malfunction | None | Material Rupture |
| 2019-04-22 | Malfunction | None | Material Rupture |
| 2019-04-22 | Malfunction | None | Break, Difficult to Remove |
| 2019-04-21 | Malfunction | None | Material Rupture |
| 2019-04-21 | Malfunction | None | Material Rupture |
| 2019-04-19 | Malfunction | None | Material Rupture |
| 2019-04-18 | Malfunction | None | Material Rupture |
| 2019-04-18 | Malfunction | None | Material Rupture |
| 2019-04-17 | Malfunction | None | Material Rupture |
| 2019-04-17 | Malfunction | None | Inflation Problem, Leak/Splash |
| 2019-04-17 | Malfunction | None | Material Rupture, Detachment of Device or Device Component |
| 2019-04-15 | Malfunction | None | Difficult to Remove, Detachment of Device or Device Component, Device Dislodged or Dislocated |
| 2019-04-11 | Malfunction | None | Break, Failure to Advance |
| 2019-04-11 | Malfunction | None | Material Rupture |
| 2019-04-10 | Malfunction | None | Material Rupture |
| 2019-04-09 | Malfunction | None | Failure to Advance, Material Deformation |
| 2019-04-08 | Malfunction | None | Material Rupture |
| 2019-04-05 | Malfunction | None | Material Rupture |
| 2019-04-05 | Malfunction | None | Material Rupture |
| 2019-04-05 | Malfunction | None | Material Rupture |
| 2019-04-04 | Malfunction | None | Material Rupture |
| 2019-04-03 | Malfunction | None | Material Rupture |
| 2019-04-02 | Malfunction | None | Material Rupture |
| 2019-03-28 | Malfunction | None | Material Rupture |
| 2019-03-28 | Malfunction | None | Entrapment of Device |
| 2019-03-28 | Malfunction | None | Material Rupture |
| 2019-03-27 | Malfunction | None | Material Rupture |
| 2019-03-27 | Malfunction | None | Material Rupture |
| 2019-03-27 | Malfunction | None | Material Rupture |
| 2019-03-27 | Malfunction | None | Material Rupture |
| 2019-03-27 | Malfunction | None | Material Rupture |
| 2019-03-26 | Malfunction | None | Material Rupture |
| 2019-03-25 | Malfunction | None | Inflation Problem, Leak/Splash |
| 2019-03-25 | Malfunction | None | Material Rupture |
| 2019-03-22 | Malfunction | None | Material Rupture |
| 2019-03-21 | Malfunction | None | Material Rupture |
| 2019-03-19 | Malfunction | None | Material Rupture |
| 2019-03-19 | Malfunction | None | Inflation Problem |
| 2019-03-19 | Malfunction | None | Material Rupture |
| 2019-03-18 | Malfunction | None | Material Rupture |
| 2019-03-15 | Malfunction | None | Material Rupture |
| 2019-03-14 | Malfunction | None | Material Rupture |
| 2019-03-14 | Malfunction | None | Material Rupture |
| 2019-03-13 | Malfunction | None | Material Rupture |
| 2019-03-13 | Malfunction | None | Material Rupture |
| 2019-03-13 | Malfunction | None | Material Rupture, Failure to Advance |
| 2019-03-11 | Malfunction | None | Material Rupture |
| 2019-03-10 | Malfunction | None | Material Rupture |
| 2019-03-08 | Malfunction | None | Material Rupture |
| 2019-03-06 | Malfunction | None | Material Rupture |
| 2019-03-05 | Malfunction | None | Material Rupture, Failure to Advance |
| 2019-03-04 | Malfunction | None | Material Rupture |
| 2019-03-01 | Malfunction | None | Material Rupture |
| 2019-03-01 | Malfunction | None | Material Rupture |
| 2019-02-28 | Malfunction | None | Material Rupture |
| 2019-02-27 | Malfunction | None | Material Rupture |
| 2019-02-25 | Malfunction | None | Material Rupture |
| 2019-02-25 | Malfunction | None | Material Rupture |
| 2019-02-20 | Malfunction | None | Device-Device Incompatibility, Material Integrity Problem, Material Twisted/Bent |
| 2019-02-20 | Malfunction | None | Material Rupture |
| 2019-02-20 | Malfunction | None | Material Rupture |
| 2019-02-19 | Malfunction | None | Material Rupture |
| 2019-02-19 | Malfunction | None | Entrapment of Device |
| 2019-02-19 | Malfunction | None | Difficult to Remove |
| 2019-02-19 | Malfunction | None | Material Rupture |
| 2019-02-19 | Malfunction | None | Material Rupture |
| 2019-02-15 | Malfunction | None | Material Rupture |
| 2019-02-14 | Malfunction | None | Break, Difficult to Remove, Detachment of Device or Device Component |
| 2019-02-14 | Malfunction | None | Material Rupture |
| 2019-02-12 | Malfunction | None | Material Rupture |
| 2019-02-12 | Malfunction | None | Material Rupture |
| 2019-02-12 | Malfunction | None | Break |
| 2019-02-08 | Malfunction | None | Material Rupture |
| 2019-02-08 | Malfunction | None | Material Rupture |
| 2019-02-08 | Malfunction | None | Material Rupture |
| 2019-02-08 | Malfunction | None | Material Rupture |
| 2019-02-08 | Malfunction | None | Material Rupture |
| 2019-02-07 | Malfunction | None | Material Rupture |
| 2019-02-06 | Malfunction | None | Material Rupture |
| 2019-02-06 | Malfunction | None | Material Rupture |
| 2019-02-05 | Malfunction | None | Material Rupture |
| 2019-02-01 | Malfunction | None | Material Rupture |
| 2019-01-31 | Malfunction | None | Failure to Advance, Detachment of Device or Device Component, Difficult to Advance |
| 2019-01-30 | Malfunction | None | Material Rupture |
| 2019-01-30 | Malfunction | None | Difficult to Advance, Device Dislodged or Dislocated |
| 2019-01-30 | Malfunction | None | Material Rupture |
| 2019-01-29 | Malfunction | None | Material Rupture |
| 2019-01-29 | Malfunction | None | Material Rupture |
| 2019-01-29 | Malfunction | None | Material Rupture |
| 2019-01-29 | Malfunction | None | Material Rupture |
| 2019-01-25 | Malfunction | None | Material Rupture |
| 2019-01-24 | Malfunction | None | Material Rupture |
| 2019-01-24 | Malfunction | None | Material Rupture |
| 2019-01-23 | Malfunction | None | Material Rupture |
| 2019-01-23 | Malfunction | None | Material Rupture |
| 2019-01-22 | Malfunction | None | Material Rupture |
| 2019-01-22 | Malfunction | None | Material Rupture |
| 2019-01-17 | Malfunction | None | Device Dislodged or Dislocated |
| 2019-01-17 | Malfunction | None | Difficult to Remove, Difficult to Advance, Material Integrity Problem |
| 2019-01-17 | Malfunction | None | Difficult to Remove |
| 2019-01-17 | Malfunction | None | Material Rupture |
| 2019-01-17 | Malfunction | None | Material Rupture |
| 2019-01-16 | Malfunction | None | Material Rupture |
| 2019-01-15 | Malfunction | None | Material Rupture |
| 2019-01-15 | Malfunction | None | Difficult to Remove, Detachment of Device or Device Component |
| 2019-01-11 | Malfunction | None | Difficult to Advance, Device Dislodged or Dislocated |
| 2019-01-10 | Malfunction | None | Material Rupture |
| 2019-01-10 | Malfunction | None | Material Rupture |
| 2019-01-09 | Malfunction | None | Material Rupture |
| 2019-01-09 | Malfunction | None | Material Rupture |
| 2019-01-09 | Malfunction | None | Material Rupture |
| 2019-01-08 | Malfunction | None | Material Rupture |
| 2019-01-07 | Malfunction | None | Material Rupture |
| 2019-01-04 | Malfunction | None | Inflation Problem, Material Rupture |
| 2018-12-27 | Malfunction | None | Material Twisted/Bent |
| 2018-12-27 | Malfunction | None | Material Rupture |
| 2018-12-27 | Malfunction | None | Device Dislodged or Dislocated |
| 2018-12-27 | Injury | None | Break, Detachment of Device or Device Component |
| 2018-12-27 | Malfunction | None | Material Rupture |
| 2018-12-27 | Malfunction | None | Material Rupture, Failure to Advance |
| 2018-12-26 | Malfunction | None | Material Rupture |
| 2018-12-26 | Malfunction | None | Material Rupture, Failure to Advance, Difficult to Advance |
| 2018-12-26 | Malfunction | None | Material Rupture |
| 2018-12-26 | Malfunction | None | Inflation Problem |
| 2018-12-26 | Malfunction | None | Break |
| 2018-12-25 | Malfunction | None | Material Rupture |
| 2018-12-21 | Malfunction | None | Material Rupture |
| 2018-12-21 | Malfunction | None | Material Rupture |
| 2018-12-21 | Malfunction | None | Material Rupture |
| 2018-12-21 | Malfunction | None | Material Rupture |
| 2018-12-20 | Malfunction | None | Material Rupture |
| 2018-12-19 | Malfunction | None | Material Rupture |
| 2018-12-18 | Malfunction | None | Material Rupture |
| 2018-12-18 | Malfunction | None | Difficult to Remove |
| 2018-12-18 | Malfunction | None | Material Rupture |
| 2018-12-17 | Malfunction | None | Material Rupture |
| 2018-12-17 | Malfunction | None | Material Rupture |
| 2018-12-12 | Malfunction | None | Material Rupture |
| 2018-12-12 | Malfunction | None | Material Rupture |
| 2018-12-11 | Malfunction | None | Material Rupture |
| 2018-12-11 | Malfunction | None | Material Rupture |
| 2018-12-06 | Malfunction | None | Material Rupture |
| 2018-12-05 | Malfunction | None | Material Rupture |
| 2018-12-05 | Malfunction | None | Material Rupture |
| 2018-12-04 | Malfunction | None | Material Rupture |
| 2018-12-03 | Malfunction | None | Material Rupture, Difficult to Advance |
| 2018-12-03 | Malfunction | None | Material Rupture |
| 2018-12-03 | Malfunction | None | Material Rupture |
| 2018-12-02 | Malfunction | None | Material Rupture |
| 2018-12-01 | Malfunction | None | Device Contamination with Chemical or Other Material |
| 2018-12-01 | Malfunction | None | Break |
| 2018-11-29 | Malfunction | None | Material Rupture |
| 2018-11-28 | Malfunction | None | Material Rupture |
| 2018-11-27 | Malfunction | None | Material Rupture |
| 2018-11-24 | Malfunction | None | Material Rupture, Difficult to Advance |
| 2018-11-21 | Malfunction | None | Material Rupture |
| 2018-11-21 | Malfunction | None | Entrapment of Device, Material Deformation |
| 2018-11-21 | Malfunction | None | Material Rupture |
| 2018-11-21 | Malfunction | None | Inflation Problem, Material Integrity Problem |
| 2018-11-20 | Malfunction | None | Material Rupture, Failure to Advance |
| 2018-11-16 | Malfunction | None | Material Rupture |
| 2018-11-15 | Malfunction | None | Material Rupture |
| 2018-11-13 | Malfunction | None | Material Rupture |
| 2018-11-13 | Malfunction | None | Material Rupture |
| 2018-11-13 | Malfunction | None | Material Rupture |
| 2018-11-13 | Malfunction | None | Material Rupture, Difficult to Advance |
| 2018-11-13 | Malfunction | None | Material Rupture |
| 2018-11-12 | Malfunction | None | Material Rupture |
| 2018-11-12 | Malfunction | None | Material Rupture |
| 2018-11-12 | Malfunction | None | Material Rupture |
| 2018-11-09 | Malfunction | None | Material Rupture |
| 2018-11-09 | Malfunction | None | Material Rupture |
| 2018-11-09 | Malfunction | None | Material Rupture |
| 2018-11-08 | Malfunction | None | Material Rupture |
| 2018-11-08 | Malfunction | None | Material Rupture |
| 2018-11-08 | Malfunction | None | Material Rupture |
| 2018-11-07 | Malfunction | None | Material Rupture |
| 2018-11-07 | Malfunction | None | Inflation Problem, Material Rupture |
| 2018-11-07 | Malfunction | None | Entrapment of Device, Difficult to Advance |
| 2018-11-06 | Malfunction | None | Material Rupture |
| 2018-11-06 | Malfunction | None | Difficult to Remove, Material Integrity Problem |
| 2018-11-06 | Malfunction | None | Material Rupture |
| 2018-11-05 | Malfunction | None | Material Rupture |
| 2018-11-05 | Malfunction | None | Material Rupture |
| 2018-11-05 | Malfunction | None | Material Rupture |
| 2018-11-02 | Malfunction | None | Material Rupture |
| 2018-10-31 | Malfunction | None | Material Rupture |
| 2018-10-31 | Malfunction | None | Material Rupture, Failure to Advance, Material Deformation |
| 2018-10-31 | Malfunction | None | Material Rupture |
| 2018-10-29 | Malfunction | None | Material Rupture |
| 2018-10-29 | Malfunction | None | Material Rupture |
| 2018-10-25 | Malfunction | None | Material Rupture |
| 2018-10-25 | Malfunction | None | Material Rupture |
| 2018-10-23 | Malfunction | None | Material Rupture |
| 2018-10-22 | Malfunction | None | Material Rupture |
| 2018-10-19 | Malfunction | None | Material Rupture |
| 2018-10-16 | Malfunction | None | Material Rupture |
| 2018-10-16 | Malfunction | None | Material Rupture |
| 2018-10-11 | Malfunction | None | Material Rupture |
| 2018-10-11 | Malfunction | None | Material Rupture |
| 2018-10-11 | Malfunction | None | Material Deformation |
| 2018-10-10 | Malfunction | None | Material Rupture |
| 2018-10-10 | Malfunction | None | Material Rupture, Difficult to Advance |
| 2018-10-10 | Malfunction | None | Material Rupture |
| 2018-10-09 | Malfunction | None | Material Rupture |
| 2018-10-04 | Malfunction | None | Material Rupture |
| 2018-10-03 | Malfunction | None | Material Rupture |
| 2018-10-02 | Malfunction | None | Material Rupture |
| 2018-10-01 | Malfunction | None | Material Rupture |
| 2018-10-01 | Malfunction | None | Material Rupture |
| 2018-09-27 | Malfunction | None | Material Rupture |
| 2018-09-26 | Malfunction | None | Material Rupture |
| 2018-09-26 | Injury | None | Difficult to Remove, Detachment of Device or Device Component |
| 2018-09-25 | Malfunction | None | Material Rupture |
| 2018-09-25 | Malfunction | None | Failure to Advance, Detachment of Device or Device Component |
| 2018-09-21 | Malfunction | None | Material Rupture |
| 2018-09-20 | Malfunction | None | Material Rupture |
| 2018-09-19 | Malfunction | None | Difficult to Remove |
| 2018-09-18 | Malfunction | None | Failure to Advance |
| 2018-09-13 | Malfunction | None | Difficult to Remove, Material Deformation |
| 2018-09-11 | Malfunction | None | Material Rupture |
| 2018-09-11 | Malfunction | None | Material Rupture, Adverse Event Without Identified Device or Use Problem |
| 2018-09-11 | Malfunction | None | Material Rupture |
| 2018-09-10 | Injury | None | Break, Difficult to Remove, Detachment of Device or Device Component |
| 2018-09-07 | Malfunction | None | Leak/Splash |
| 2018-09-05 | Malfunction | None | Material Rupture |
| 2018-09-04 | Malfunction | None | Material Rupture, Adverse Event Without Identified Device or Use Problem |
| 2018-08-29 | Malfunction | None | Material Rupture |
| 2018-08-22 | Malfunction | None | Material Rupture |
| 2018-08-21 | Malfunction | None | Break, Material Deformation |
| 2018-08-21 | Malfunction | None | Material Rupture |
| 2018-08-10 | Malfunction | None | Material Rupture |
| 2018-08-07 | Malfunction | None | Material Rupture |
| 2018-08-06 | Malfunction | None | Material Rupture |
| 2018-07-31 | Malfunction | None | Material Rupture |
| 2018-07-31 | Malfunction | None | Material Rupture |
| 2018-07-30 | Malfunction | None | Material Rupture |
| 2018-07-30 | Malfunction | None | Failure to Advance |
| 2018-07-27 | Malfunction | None | Material Rupture |
| 2018-07-20 | Malfunction | None | Material Rupture |
| 2018-07-20 | Malfunction | None | Material Rupture |
| 2018-07-18 | Malfunction | None | Material Rupture |
| 2018-07-17 | Malfunction | None | Material Rupture |
| 2018-07-17 | Malfunction | None | Material Rupture |
| 2018-07-17 | Malfunction | None | Detachment of Device or Device Component |
| 2018-07-10 | Malfunction | None | Material Rupture |
| 2018-07-10 | Malfunction | None | Material Rupture |
| 2018-07-09 | Malfunction | None | Material Rupture |
| 2018-07-06 | Malfunction | None | Failure to Advance |
| 2018-07-06 | Malfunction | None | Material Rupture |
| 2018-07-04 | Malfunction | None | Material Rupture |
| 2018-07-04 | Malfunction | None | Material Rupture |
| 2018-07-03 | Malfunction | None | Material Rupture |
| 2018-06-29 | Malfunction | None | Difficult to Remove, Detachment of Device or Device Component |
| 2018-06-28 | Malfunction | None | Material Rupture |
| 2018-06-28 | Malfunction | None | Material Deformation |
| 2018-06-27 | Malfunction | None | Material Rupture |
| 2018-06-26 | Malfunction | None | Material Rupture |
| 2018-06-25 | Malfunction | None | Material Rupture |
| 2018-06-20 | Malfunction | None | Entrapment of Device |
| 2018-06-19 | Malfunction | None | Material Rupture |
| 2018-06-19 | Malfunction | None | Material Rupture |
| 2018-06-13 | Malfunction | None | Material Rupture |
| 2018-06-11 | Malfunction | None | Break |
| 2018-06-11 | Malfunction | None | Material Rupture |
| 2018-06-01 | Malfunction | None | Material Rupture |
| 2018-06-01 | Malfunction | None | Material Rupture |
| 2018-05-30 | Injury | None | Break, Difficult to Remove |
| 2018-05-23 | Malfunction | None | Material Rupture |
| 2018-05-17 | Malfunction | None | Material Rupture |
| 2018-05-17 | Injury | None | Break, Difficult to Remove, Device Or Device Fragments Location Unknown, Detachment of Device or Device Component |
| 2018-05-15 | Malfunction | None | Material Rupture |
| 2018-05-15 | Malfunction | None | Material Rupture |
| 2018-05-10 | Malfunction | None | Material Rupture |
| 2018-05-01 | Malfunction | None | Break, Difficult to Remove |
| 2018-04-24 | Malfunction | None | Break |
| 2018-04-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-16 | Injury | None | Break, Detachment Of Device Component, Peeled/Delaminated |
| 2018-03-15 | Malfunction | None | Difficult to Remove |
| 2018-03-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-25 | Malfunction | None | Hole In Material, Material Rupture |
| 2018-01-03 | Malfunction | None | Detachment Of Device Component |
| 2016-10-18 | Injury | Hemorrhage/Blood Loss/Bleeding | Insufficient Information |
| 2014-11-04 | Injury | None | Device Operates Differently Than Expected |
| 2014-06-19 | Injury | None | Patient-Device Incompatibility |
| 2014-05-28 | Malfunction | None | Sticking, Device Displays Incorrect Message |
| 2014-05-27 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-05-13 | Malfunction | None | Sticking |
| 2014-05-09 | Injury | None | Device Operates Differently Than Expected |
| 2014-04-17 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-04-17 | Malfunction | None | Battery Problem, Charging Problem |
| 2014-04-15 | Malfunction | None | Sticking |
| 2014-04-08 | Malfunction | None | Sticking |
| 2014-04-01 | Injury | None | Device Operates Differently Than Expected |
| 2014-03-26 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-03-11 | Malfunction | None | Sticking |
| 2014-03-10 | Malfunction | None | Sticking |
| 2014-03-06 | Injury | None | Device Operates Differently Than Expected |
| 2014-03-03 | Malfunction | None | Sticking, Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2014-02-25 | Injury | None | Sticking, Device Operates Differently Than Expected |
| 2014-02-12 | Malfunction | None | Sticking |
| 2014-01-22 | Malfunction | None | Device Operates Differently Than Expected |
| 2014-01-22 | Malfunction | None | Sticking |
| 2014-01-15 | Malfunction | None | Sticking |
| 2014-01-08 | Malfunction | None | Sticking |
| 2013-12-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2013-12-19 | Injury | None | Sticking |
| 2013-12-09 | Malfunction | None | Sticking, Device Operates Differently Than Expected |
| 2013-12-04 | Malfunction | None | None |
| 2013-12-02 | Malfunction | None | None |
| 2013-11-27 | Malfunction | None | None |
| 2013-11-25 | Malfunction | None | None |
| 2013-11-20 | Malfunction | None | None |
| 2013-11-15 | Malfunction | None | None |
| 2013-11-11 | Malfunction | None | None |
| 2013-11-08 | Malfunction | None | None |
| 2013-11-07 | Injury | None | None |
| 2013-11-06 | Injury | None | None |
| 2013-10-28 | Malfunction | None | None |
| 2013-10-18 | Malfunction | None | None |
| 2013-10-09 | Malfunction | None | None |
| 2013-10-09 | Injury | None | None |
| 2013-09-25 | Malfunction | None | None |
| 2013-09-25 | Malfunction | None | None |
| 2013-09-23 | Malfunction | None | None |
| 2013-09-20 | Injury | None | None |
| 2013-09-17 | Malfunction | None | None |
| 2013-09-06 | Malfunction | None | None |
| 2013-09-03 | Malfunction | None | None |
| 2013-09-03 | Malfunction | None | None |
| 2013-08-30 | Malfunction | None | None |
| 2013-08-29 | Injury | None | None |
| 2013-08-28 | Malfunction | None | None |
| 2013-08-23 | Malfunction | None | None |
| 2013-08-14 | Malfunction | None | None |
| 2013-08-13 | Malfunction | None | None |
| 2013-08-12 | Malfunction | None | None |
| 2013-08-12 | Malfunction | None | None |
| 2013-08-10 | Malfunction | None | None |
| 2013-08-07 | Injury | None | None |
| 2013-08-06 | Malfunction | None | None |
| 2013-07-12 | Malfunction | None | None |
| 2013-07-12 | Malfunction | None | None |
| 2013-07-10 | Malfunction | None | None |
| 2013-07-06 | Malfunction | None | None |
| 2013-07-02 | Injury | None | None |
| 2013-06-18 | Malfunction | None | None |
| 2013-06-11 | Malfunction | None | None |
| 2013-06-07 | Malfunction | None | None |
| 2013-06-06 | Malfunction | None | None |
| 2013-05-30 | Injury | None | None |
| 2013-05-19 | Injury | None | None |
| 2013-05-17 | Malfunction | None | None |
| 2013-05-02 | Malfunction | None | None |
| 2013-04-23 | Malfunction | None | None |
| 2013-04-22 | Malfunction | None | None |
| 2013-04-10 | Malfunction | None | None |
| 2013-04-03 | Malfunction | None | None |
| 2013-03-27 | Malfunction | None | None |
| 2013-03-20 | Malfunction | None | None |
| 2013-03-20 | Malfunction | None | None |
| 2013-03-19 | Malfunction | None | None |
| 2013-03-19 | Injury | None | None |
| 2013-03-17 | Malfunction | None | None |
| 2013-03-04 | Malfunction | None | None |
| 2013-02-27 | Malfunction | None | None |
| 2013-02-26 | Malfunction | None | None |
| 2013-02-25 | Injury | None | None |
| 2013-02-21 | Malfunction | None | None |
| 2013-02-21 | Malfunction | None | None |
| 2013-02-04 | Malfunction | None | None |
| 2013-01-31 | Injury | None | None |
| 2013-01-25 | Injury | None | None |
| 2013-01-24 | Malfunction | None | None |
| 2013-01-18 | Death | None | None |
| 2013-01-14 | Malfunction | None | None |
| 2013-01-14 | Malfunction | None | None |
| 2013-01-08 | Malfunction | None | None |
| 2013-01-07 | Malfunction | None | None |
| 2012-12-28 | Malfunction | None | None |
| 2012-12-03 | Malfunction | None | None |
| 2012-12-03 | Injury | None | None |
| 2012-11-20 | Injury | None | None |
| 2012-11-20 | Injury | None | None |
| 2012-11-16 | Malfunction | None | None |
| 2012-11-15 | Malfunction | None | None |
| 2012-11-12 | Malfunction | None | None |
| 2012-11-05 | Malfunction | None | None |
| 2012-10-25 | Malfunction | None | None |
| 2012-10-25 | Injury | None | None |
| 2012-10-18 | Malfunction | None | None |
| 2012-10-18 | Malfunction | None | None |
| 2012-10-05 | Injury | None | None |
| 2012-10-04 | Injury | None | None |
| 2012-10-03 | Malfunction | None | None |
| 2012-09-27 | Malfunction | None | None |
| 2012-09-26 | Injury | None | None |
| 2012-09-18 | Injury | None | None |
| 2012-09-14 | Malfunction | None | None |
| 2012-09-12 | Malfunction | None | None |
| 2012-08-31 | Malfunction | None | None |
| 2012-08-31 | Malfunction | None | None |
| 2012-08-30 | Malfunction | None | None |
| 2012-08-28 | Injury | None | None |
| 2012-08-27 | Malfunction | None | None |
| 2012-08-27 | Injury | None | None |
| 2012-08-21 | Injury | None | None |
| 2012-08-08 | Malfunction | None | None |
| 2012-08-01 | Malfunction | None | None |
| 2012-08-01 | Malfunction | None | None |
| 2012-07-30 | Malfunction | None | None |
| 2012-07-26 | Malfunction | None | None |
| 2012-07-24 | Malfunction | None | None |
| 2012-07-18 | Malfunction | None | None |
| 2012-07-18 | Malfunction | None | None |
| 2012-07-14 | Malfunction | None | None |
| 2012-07-12 | Injury | None | None |
| 2012-07-03 | Malfunction | None | None |
| 2012-06-25 | Malfunction | None | None |
| 2012-06-15 | Malfunction | None | None |
| 2012-06-07 | Malfunction | None | None |
| 2012-06-01 | Malfunction | None | None |
| 2012-05-29 | Malfunction | None | None |
| 2012-05-29 | Malfunction | None | None |
| 2012-05-23 | Malfunction | None | None |
| 2012-05-21 | Injury | None | None |
| 2012-05-21 | Malfunction | None | None |
| 2012-05-17 | Malfunction | None | None |
| 2012-05-11 | Malfunction | None | None |
| 2012-04-04 | Malfunction | None | None |
| 2012-03-14 | Injury | None | None |
| 2012-02-15 | Injury | None | None |
| 2011-06-13 | Malfunction | None | None |
| 2011-06-11 | Malfunction | None | None |
| 2011-05-02 | Malfunction | None | None |
| 2008-06-15 | Injury | None | None |
| 2007-07-06 | Malfunction | None | Battery Problem |