CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
This device is manufactured by BOSTON SCIENTIFIC CORPORATION, ST JUDE MEDICAL.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2024-05-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break |
| 2024-05-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component |
| 2024-04-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Inflation Problem |
| 2024-01-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Inflation Problem |
| 2023-12-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break |
| 2023-11-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break, Material Deformation |
| 2023-09-01 | Malfunction | Insufficient Information | None |
| 2023-07-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Break |
| 2023-06-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Rupture |
| 2022-11-01 | Malfunction | None | Break |
| 2022-10-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Contamination, Packaging Problem |
| 2022-10-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Contamination |
| 2022-02-25 | Injury | None | Break |
| 2022-01-11 | Malfunction | None | Defective Device |
| 2019-08-29 | Malfunction | None | Break |
| 2019-08-23 | Malfunction | None | Break |
| 2019-08-20 | Malfunction | None | Break |
| 2019-08-08 | Malfunction | None | Break |
| 2019-08-08 | Malfunction | None | Material Rupture |
| 2019-07-31 | Malfunction | None | Material Rupture |
| 2019-07-18 | Malfunction | None | Break |
| 2019-07-16 | Malfunction | None | Inflation Problem |
| 2019-07-08 | Malfunction | None | Break |
| 2019-07-06 | Malfunction | None | Material Deformation |
| 2019-07-04 | Malfunction | None | Leak/Splash |
| 2019-06-20 | Malfunction | None | Material Deformation |
| 2019-06-19 | Malfunction | None | Material Deformation |
| 2019-06-17 | Malfunction | None | Difficult to Advance, Material Deformation |
| 2019-06-13 | Malfunction | None | Break |
| 2019-06-13 | Malfunction | None | Break |
| 2019-06-11 | Malfunction | None | Break |
| 2019-06-11 | Malfunction | None | Break |
| 2019-06-11 | Malfunction | None | Break |
| 2019-06-11 | Malfunction | None | Break |
| 2019-06-04 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-04 | Malfunction | None | Break |
| 2019-06-04 | Malfunction | None | Break |
| 2019-05-28 | Malfunction | None | Material Deformation |
| 2019-05-23 | Malfunction | None | Break |
| 2019-05-20 | Malfunction | None | Break |
| 2019-05-20 | Malfunction | None | Material Rupture |
| 2019-05-20 | Malfunction | None | Material Rupture |
| 2019-05-14 | Malfunction | None | Break |
| 2019-05-13 | Malfunction | None | Material Deformation |
| 2019-05-12 | Malfunction | None | Material Rupture |
| 2019-05-10 | Malfunction | None | Break |
| 2019-05-08 | Malfunction | None | Break |
| 2019-05-07 | Malfunction | None | Break |
| 2019-05-05 | Malfunction | None | Material Deformation |
| 2019-04-28 | Malfunction | None | Material Deformation |
| 2019-04-26 | Malfunction | None | Break |
| 2019-04-25 | Malfunction | None | Material Deformation |
| 2019-04-24 | Malfunction | None | Failure to Advance |
| 2019-04-23 | Malfunction | None | Break |
| 2019-04-19 | Malfunction | None | Break |
| 2019-04-18 | Malfunction | None | Break |
| 2019-04-18 | Malfunction | None | Break |
| 2019-04-17 | Malfunction | None | Break |
| 2019-04-16 | Malfunction | None | Failure to Advance |
| 2019-04-16 | Malfunction | None | Failure to Advance |
| 2019-04-15 | Malfunction | None | Failure to Advance |
| 2019-04-15 | Injury | None | Break |
| 2019-04-10 | Malfunction | None | Failure to Advance |
| 2019-04-09 | Malfunction | None | Entrapment of Device |
| 2019-04-08 | Malfunction | None | Material Deformation |
| 2019-04-08 | Malfunction | None | Failure to Advance |
| 2019-04-05 | Malfunction | None | Failure to Advance |
| 2019-04-04 | Malfunction | None | Break |
| 2019-04-03 | Malfunction | None | Break |
| 2019-04-02 | Malfunction | None | Inflation Problem |
| 2019-04-02 | Malfunction | None | Break |
| 2019-04-02 | Malfunction | None | Device Contamination with Chemical or Other Material |
| 2019-04-01 | Malfunction | None | Failure to Advance |
| 2019-03-29 | Malfunction | None | Break |
| 2019-03-28 | Malfunction | None | Material Deformation |
| 2019-03-22 | Malfunction | None | Inflation Problem, Leak/Splash |
| 2019-03-21 | Malfunction | None | Failure to Advance |
| 2019-03-18 | Malfunction | None | Failure to Advance |
| 2019-03-18 | Malfunction | None | Break |
| 2019-03-14 | Malfunction | None | Failure to Advance |
| 2019-03-13 | Malfunction | None | Failure to Advance |
| 2019-03-10 | Malfunction | None | Break |
| 2019-03-08 | Malfunction | None | Failure to Advance |
| 2019-03-08 | Malfunction | None | Material Deformation |
| 2019-03-06 | Malfunction | None | Failure to Advance |
| 2019-03-06 | Malfunction | None | Inflation Problem |
| 2019-03-05 | Malfunction | None | Inflation Problem |
| 2019-03-03 | Malfunction | None | Break |
| 2019-03-03 | Malfunction | None | Break |
| 2019-02-28 | Malfunction | None | Break |
| 2019-02-26 | Malfunction | None | Material Deformation |
| 2019-02-25 | Malfunction | None | Break |
| 2019-02-19 | Malfunction | None | Failure to Advance |
| 2019-02-18 | Malfunction | None | Failure to Advance |
| 2019-02-15 | Malfunction | None | Break |
| 2019-02-14 | Malfunction | None | Break |
| 2019-02-14 | Malfunction | None | Break |
| 2019-02-14 | Malfunction | None | Break |
| 2019-02-14 | Malfunction | None | Failure to Advance |
| 2019-02-13 | Malfunction | None | Break |
| 2019-02-07 | Malfunction | None | Insufficient Information |
| 2019-02-04 | Malfunction | None | Break |
| 2019-02-01 | Malfunction | None | Failure to Advance |
| 2019-02-01 | Malfunction | None | Difficult to Advance, Material Deformation |
| 2019-02-01 | Malfunction | None | Entrapment of Device, Material Deformation |
| 2019-01-31 | Malfunction | None | Failure to Advance |
| 2019-01-24 | Malfunction | None | Material Rupture |
| 2019-01-21 | Malfunction | None | Material Deformation, Adverse Event Without Identified Device or Use Problem |
| 2019-01-17 | Malfunction | None | Break, Failure to Advance |
| 2019-01-14 | Malfunction | None | Failure to Advance |
| 2019-01-14 | Malfunction | None | Material Deformation |
| 2019-01-11 | Malfunction | None | Break |
| 2019-01-10 | Malfunction | None | Material Deformation |
| 2019-01-09 | Malfunction | None | Break |
| 2019-01-04 | Malfunction | None | Failure to Advance |
| 2019-01-03 | Malfunction | None | Material Deformation |
| 2018-12-24 | Malfunction | None | Failure to Advance |
| 2018-12-24 | Malfunction | None | Failure to Advance |
| 2018-12-21 | Malfunction | None | Detachment of Device or Device Component |
| 2018-12-20 | Malfunction | None | Inflation Problem |
| 2018-12-18 | Malfunction | None | Break |
| 2018-12-17 | Malfunction | None | Break |
| 2018-12-14 | Malfunction | None | Failure to Advance |
| 2018-12-14 | Malfunction | None | Break |
| 2018-12-14 | Malfunction | None | Failure to Advance |
| 2018-12-10 | Malfunction | None | Material Deformation |
| 2018-12-07 | Malfunction | None | Contamination, Unsealed Device Packaging |
| 2018-12-05 | Malfunction | None | Failure to Advance |
| 2018-11-30 | Malfunction | None | Break |
| 2018-11-28 | Malfunction | None | Material Rupture |
| 2018-11-22 | Malfunction | None | Break |
| 2018-11-22 | Malfunction | None | Break |
| 2018-11-21 | Malfunction | None | Material Rupture, Adverse Event Without Identified Device or Use Problem |
| 2018-11-21 | Malfunction | None | Failure to Advance |
| 2018-11-19 | Malfunction | None | Failure to Advance |
| 2018-11-19 | Malfunction | None | Material Deformation |
| 2018-11-19 | Malfunction | None | Break |
| 2018-11-15 | Malfunction | None | Failure to Advance |
| 2018-11-13 | Malfunction | None | Failure to Advance |
| 2018-11-13 | Malfunction | None | Failure to Advance |
| 2018-11-09 | Malfunction | None | Break, Adverse Event Without Identified Device or Use Problem |
| 2018-11-08 | Malfunction | None | Break |
| 2018-11-08 | Malfunction | None | Material Deformation |
| 2018-11-07 | Malfunction | None | Break |
| 2018-11-06 | Malfunction | None | Break |
| 2018-11-05 | Malfunction | None | Break |
| 2018-10-26 | Malfunction | None | Material Deformation |
| 2018-10-25 | Malfunction | None | Failure to Advance |
| 2018-10-25 | Malfunction | None | Failure to Advance |
| 2018-10-19 | Malfunction | None | Failure to Advance |
| 2018-10-19 | Malfunction | None | Material Deformation, Adverse Event Without Identified Device or Use Problem |
| 2018-10-17 | Malfunction | None | Break |
| 2018-10-17 | Malfunction | None | Break |
| 2018-10-17 | Malfunction | None | Break |
| 2018-10-12 | Malfunction | None | Material Deformation |
| 2018-10-11 | Malfunction | None | Failure to Advance |
| 2018-10-11 | Malfunction | None | Material Integrity Problem |
| 2018-10-11 | Malfunction | None | Break |
| 2018-10-10 | Malfunction | None | Break |
| 2018-10-10 | Malfunction | None | Break |
| 2018-10-09 | Malfunction | None | Failure to Advance |
| 2018-10-08 | Malfunction | None | Break |
| 2018-10-08 | Malfunction | None | Material Rupture |
| 2018-10-03 | Malfunction | None | Inflation Problem |
| 2018-09-28 | Malfunction | None | Break, Material Rupture |
| 2018-09-27 | Malfunction | None | Failure to Advance |
| 2018-09-26 | Malfunction | None | Failure to Advance |
| 2018-09-25 | Malfunction | None | Material Rupture |
| 2018-09-25 | Malfunction | None | Break |
| 2018-09-24 | Malfunction | None | Failure to Advance |
| 2018-09-20 | Malfunction | None | Failure to Advance |
| 2018-09-19 | Malfunction | None | Material Rupture |
| 2018-09-18 | Malfunction | None | Failure to Advance |
| 2018-09-17 | Malfunction | None | Material Separation |
| 2018-09-17 | Malfunction | None | Failure to Advance |
| 2018-09-13 | Malfunction | None | Break, Adverse Event Without Identified Device or Use Problem |
| 2018-09-13 | Malfunction | None | Break |
| 2018-09-12 | Malfunction | None | Break |
| 2018-09-11 | Malfunction | None | Break |
| 2018-09-10 | Malfunction | None | Material Rupture, Adverse Event Without Identified Device or Use Problem |
| 2018-09-06 | Malfunction | None | Failure to Advance |
| 2018-09-06 | Malfunction | None | Failure to Advance, Adverse Event Without Identified Device or Use Problem |
| 2018-09-06 | Malfunction | None | Failure to Advance |
| 2018-09-04 | Malfunction | None | Break |
| 2018-08-31 | Malfunction | None | Material Deformation |
| 2018-08-30 | Malfunction | None | Material Integrity Problem |
| 2018-08-30 | Malfunction | None | Failure to Advance |
| 2018-08-29 | Malfunction | None | Failure to Advance |
| 2018-08-28 | Malfunction | None | Material Integrity Problem |
| 2018-08-28 | Malfunction | None | Failure to Advance |
| 2018-08-28 | Malfunction | None | Break |
| 2018-08-25 | Malfunction | None | Break |
| 2018-08-25 | Malfunction | None | Difficult to Advance |
| 2018-08-22 | Malfunction | None | Failure to Advance |
| 2018-08-21 | Malfunction | None | Break |
| 2018-08-20 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-20 | Malfunction | None | Break |
| 2018-08-20 | Malfunction | None | Break |
| 2018-08-17 | Malfunction | None | Failure to Advance |
| 2018-08-13 | Malfunction | None | Break |
| 2018-08-10 | Malfunction | None | Failure to Advance |
| 2018-08-10 | Malfunction | None | Break |
| 2018-08-08 | Malfunction | None | Break |
| 2018-08-06 | Malfunction | None | Failure to Advance |
| 2018-07-25 | Malfunction | None | Break |
| 2018-07-23 | Malfunction | None | Failure to Advance |
| 2018-07-19 | Malfunction | None | Material Rupture |
| 2018-07-18 | Malfunction | None | Material Rupture |
| 2018-07-17 | Malfunction | None | Failure to Advance, Adverse Event Without Identified Device or Use Problem |
| 2018-07-13 | Malfunction | None | Break |
| 2018-07-12 | Malfunction | None | Break |
| 2018-07-11 | Malfunction | None | Material Rupture |
| 2018-07-10 | Malfunction | None | Material Rupture |
| 2018-07-08 | Malfunction | None | Break |
| 2018-07-05 | Malfunction | None | Failure to Advance, Material Deformation |
| 2018-07-03 | Malfunction | None | Failure to Advance |
| 2018-06-30 | Malfunction | None | Break, Device Damaged Prior to Use |
| 2018-06-20 | Malfunction | None | Break |
| 2018-06-19 | Malfunction | None | Failure to Advance |
| 2018-06-19 | Malfunction | None | Inflation Problem |
| 2018-06-15 | Malfunction | None | Failure to Advance |
| 2018-06-08 | Malfunction | None | Material Deformation |
| 2018-06-06 | Malfunction | None | Break |
| 2018-06-06 | Malfunction | None | Break |
| 2018-06-05 | Malfunction | None | Failure to Advance |
| 2018-05-31 | Malfunction | None | Failure to Advance |
| 2018-05-29 | Malfunction | None | Failure to Advance |
| 2018-05-28 | Malfunction | None | Failure to Advance |
| 2018-05-28 | Malfunction | None | Failure to Advance |
| 2018-05-24 | Malfunction | None | Break, Device Damaged Prior to Use |
| 2018-05-22 | Malfunction | None | Failure to Advance |
| 2018-05-22 | Malfunction | None | Inflation Problem |
| 2018-05-21 | Injury | None | Detachment Of Device Component |
| 2018-05-17 | Malfunction | None | Failure to Advance |
| 2018-05-16 | Malfunction | None | Inflation Problem |
| 2018-05-15 | Malfunction | None | Inflation Problem |
| 2018-05-10 | Injury | None | Break |
| 2018-04-27 | Malfunction | None | Break |
| 2018-04-27 | Malfunction | None | Break |
| 2018-04-27 | Malfunction | None | Break |
| 2018-04-25 | Malfunction | None | Failure to Advance |
| 2018-04-24 | Malfunction | None | Inflation Problem |
| 2018-04-20 | Malfunction | None | Inflation Problem |
| 2018-04-20 | Malfunction | None | Material Rupture |
| 2018-04-19 | Malfunction | None | Failure to Advance |
| 2018-04-18 | Malfunction | None | Break |
| 2018-04-17 | Malfunction | None | Failure to Advance |
| 2018-04-13 | Malfunction | None | Failure to Advance |
| 2018-04-13 | Malfunction | None | Failure to Advance |
| 2018-04-12 | Malfunction | None | Failure to Advance |
| 2018-04-11 | Malfunction | None | Kinked |
| 2018-04-09 | Malfunction | None | Break |
| 2018-04-04 | Malfunction | None | Break |
| 2018-04-04 | Malfunction | Foreign Body In Patient | Therapeutic or Diagnostic Output Failure |
| 2018-04-02 | Malfunction | None | Material Rupture |
| 2018-03-28 | Malfunction | None | Failure to Advance |
| 2018-03-27 | Malfunction | None | Failure to Advance |
| 2018-03-21 | Malfunction | None | Kinked |
| 2018-03-15 | Malfunction | None | Material Rupture |
| 2018-03-15 | Malfunction | None | Break |
| 2018-03-15 | Malfunction | None | Failure to Advance |
| 2018-03-15 | Injury | None | Detachment Of Device Component, Material Rupture |
| 2018-03-15 | Malfunction | None | Break, Device Damaged Prior to Use |
| 2018-03-13 | Malfunction | None | Material Rupture |
| 2018-03-08 | Malfunction | None | Break |
| 2018-03-07 | Malfunction | None | Kinked |
| 2018-03-01 | Malfunction | None | Failure to Advance |
| 2018-02-28 | Malfunction | None | Failure to Advance |
| 2018-02-26 | Malfunction | None | Failure to Advance |
| 2018-02-24 | Malfunction | None | Failure to Advance |
| 2018-02-23 | Malfunction | None | Failure to Advance |
| 2018-02-20 | Malfunction | None | Failure to Advance |
| 2018-02-08 | Malfunction | None | Break |
| 2018-01-23 | Malfunction | None | Break |
| 2018-01-18 | Malfunction | None | Break |
| 2018-01-18 | Malfunction | None | Break, Device Damaged Prior to Use |
| 2018-01-17 | Injury | None | Break |
| 2018-01-13 | Malfunction | None | Fracture |
| 2018-01-11 | Injury | None | Material Rupture, Material Deformation |
| 2018-01-11 | Malfunction | None | Break |
| 2018-01-10 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-04 | Malfunction | None | Material Rupture |
| 2018-01-04 | Malfunction | None | Material Rupture |
| 2018-01-03 | Malfunction | None | Failure to Advance |
| 2017-12-31 | Malfunction | None | Kinked |
| 2017-12-27 | Malfunction | None | Kinked |
| 2017-12-27 | Malfunction | None | Material Rupture |
| 2017-12-26 | Malfunction | None | Break |
| 2017-12-25 | Malfunction | None | Failure to Advance |
| 2017-12-25 | Malfunction | None | Material Deformation |
| 2017-12-21 | Malfunction | None | Break, Device Damaged Prior to Use |
| 2017-12-15 | Malfunction | None | Material Rupture |
| 2017-12-15 | Malfunction | None | Kinked |
| 2017-12-13 | Malfunction | None | Break |
| 2017-12-07 | Malfunction | None | Break |
| 2017-12-05 | Malfunction | None | Material Rupture |
| 2017-12-05 | Malfunction | None | Break, Material Rupture |
| 2017-12-04 | Malfunction | None | Material Rupture |
| 2017-12-04 | Malfunction | None | Break |
| 2017-11-29 | Malfunction | None | Failure to Advance |
| 2017-11-27 | Malfunction | None | Break |
| 2017-11-27 | Malfunction | None | Break |
| 2017-11-22 | Death | None | Difficult to Remove, Material Rupture, Detachment of Device or Device Component |
| 2017-11-20 | Malfunction | None | Unsealed Device Packaging |
| 2017-11-17 | Malfunction | None | Break |
| 2017-11-16 | Malfunction | None | Failure to Advance |
| 2017-11-16 | Malfunction | None | Device Dislodged or Dislocated |
| 2017-11-15 | Malfunction | None | Break, Device Damaged Prior to Use |
| 2017-11-13 | Malfunction | None | Kinked |
| 2017-11-11 | Malfunction | None | Kinked |
| 2017-11-09 | Malfunction | None | Failure to Advance |
| 2017-11-09 | Malfunction | None | Material Rupture |
| 2017-11-08 | Malfunction | None | Break |
| 2017-11-01 | Malfunction | None | Break |
| 2017-10-28 | Malfunction | None | Material Rupture |
| 2017-10-27 | Malfunction | None | Break, Device Damaged Prior to Use |
| 2017-10-20 | Malfunction | None | Failure to Advance |
| 2017-10-19 | Malfunction | None | Failure to Advance |
| 2017-10-13 | Malfunction | None | Failure to Advance |
| 2017-10-12 | Malfunction | None | Break |
| 2017-10-09 | Malfunction | None | Failure to Advance |
| 2017-10-04 | Malfunction | None | Failure to Advance |
| 2017-09-29 | Malfunction | None | Material Rupture |
| 2017-09-27 | Malfunction | None | Material Rupture |
| 2017-09-12 | Malfunction | None | Break |
| 2017-09-11 | Malfunction | None | Break |
| 2017-09-08 | Malfunction | None | Kinked |
| 2017-09-08 | Malfunction | None | Material Rupture |
| 2017-09-06 | Malfunction | None | Bent |
| 2017-08-31 | Malfunction | None | Break |
| 2017-08-23 | Malfunction | None | Material Rupture |
| 2017-08-22 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-17 | Malfunction | None | Failure to Advance |
| 2017-08-17 | Malfunction | None | Failure to Advance |
| 2017-08-14 | Malfunction | None | Break |
| 2017-08-14 | Malfunction | None | Break |
| 2017-08-14 | Malfunction | None | Kinked, Failure to Advance |
| 2017-08-09 | Malfunction | None | Failure to Advance |
| 2017-08-09 | Malfunction | None | Failure to Advance |
| 2017-08-04 | Malfunction | None | Break |
| 2017-08-03 | Malfunction | None | Break |
| 2017-08-01 | Malfunction | None | Material Deformation |
| 2017-07-29 | Malfunction | None | Kinked, Device Damaged Prior to Use |
| 2017-07-24 | Malfunction | None | Hole In Material |
| 2017-07-19 | Malfunction | None | Break |
| 2017-07-18 | Malfunction | None | Break |
| 2017-07-14 | Malfunction | None | Detachment Of Device Component |
| 2017-07-11 | Malfunction | None | Material Rupture |
| 2017-07-10 | Malfunction | None | Kinked |
| 2017-07-06 | Malfunction | None | Failure to Advance |
| 2017-06-28 | Malfunction | None | Failure to Advance |
| 2017-06-22 | Malfunction | None | Failure to Advance |
| 2017-06-21 | Malfunction | None | Failure to Advance |
| 2017-06-15 | Malfunction | None | Kinked |
| 2017-06-14 | Malfunction | None | Kinked |
| 2017-06-08 | Malfunction | None | Break |
| 2017-06-05 | Malfunction | None | Break |
| 2017-06-04 | Malfunction | None | Failure to Advance |
| 2017-05-26 | Malfunction | None | Kinked |
| 2017-05-23 | Malfunction | None | Device Markings/Labelling Problem |
| 2017-05-22 | Malfunction | None | Failure to Advance |
| 2017-05-16 | Injury | None | Deflation Problem |
| 2017-05-13 | Malfunction | None | Break |
| 2017-05-10 | Malfunction | None | Failure to Advance |
| 2017-05-09 | Malfunction | None | Hole In Material, Leak/Splash |
| 2017-05-08 | Malfunction | None | Kinked |
| 2017-04-28 | Malfunction | None | Failure to Advance |
| 2017-04-28 | Malfunction | None | Failure to Advance |
| 2017-04-27 | Malfunction | None | Failure to Advance |
| 2017-04-25 | Malfunction | None | Break |
| 2017-04-25 | Malfunction | None | Break |
| 2017-04-19 | Malfunction | None | Failure to Advance |
| 2017-04-19 | Malfunction | None | Break |
| 2017-04-18 | Malfunction | None | Break |
| 2017-04-17 | Malfunction | None | Break |
| 2017-04-14 | Malfunction | None | Material Rupture |
| 2017-04-13 | Malfunction | None | Failure to Advance |
| 2017-04-13 | Injury | None | Break |
| 2017-04-06 | Malfunction | None | Failure to Advance |
| 2017-03-30 | Malfunction | None | Failure to Advance |
| 2017-03-24 | Malfunction | None | Break |
| 2017-03-24 | Malfunction | None | Failure to Advance |
| 2017-03-24 | Malfunction | None | Failure to Advance |
| 2017-03-23 | Malfunction | None | Material Rupture |
| 2017-03-22 | Malfunction | None | Material Rupture |
| 2017-03-21 | Malfunction | None | Failure to Advance |
| 2017-03-10 | Malfunction | None | Failure to Advance |
| 2017-03-09 | Malfunction | None | Material Rupture |
| 2017-03-09 | Malfunction | None | Failure to Advance |
| 2017-03-07 | Malfunction | None | Kinked |
| 2017-02-27 | Malfunction | None | Break |
| 2017-02-27 | Malfunction | None | Break |
| 2017-02-27 | Malfunction | None | Failure to Advance |
| 2017-02-27 | Malfunction | None | Kinked |
| 2017-02-25 | Injury | None | Difficult to Remove |
| 2017-02-25 | Malfunction | None | Break |
| 2017-02-22 | Malfunction | None | Failure to Advance |
| 2017-02-21 | Malfunction | None | Failure to Advance |
| 2017-02-15 | Malfunction | None | Break |
| 2017-02-15 | Malfunction | None | Break |
| 2017-02-14 | Malfunction | None | Kinked |
| 2017-02-13 | Malfunction | None | Material Rupture |
| 2017-02-11 | Malfunction | None | Break, Device Damaged Prior to Use |
| 2017-02-08 | Malfunction | None | Break |
| 2017-01-30 | Malfunction | None | Break |
| 2017-01-24 | Malfunction | None | Break |
| 2017-01-23 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-17 | Malfunction | None | Material Rupture |
| 2017-01-12 | Malfunction | Insufficient Information | Nonstandard Device |
| 2017-01-09 | Malfunction | None | Break |
| 2017-01-09 | Malfunction | None | Break |
| 2017-01-04 | Malfunction | None | Break, Device Damaged Prior to Use |
| 2016-12-30 | Malfunction | None | Hole In Material |
| 2016-12-30 | Malfunction | None | Inflation Problem |
| 2016-12-30 | Malfunction | None | Hole In Material |
| 2016-12-29 | Malfunction | None | Failure to Advance |
| 2016-12-28 | Malfunction | None | Break |
| 2016-12-28 | Malfunction | None | Kinked |
| 2016-12-26 | Malfunction | None | Break |
| 2016-12-23 | Malfunction | None | Failure to Advance |
| 2016-12-23 | Malfunction | None | Failure to Advance |
| 2016-12-23 | Malfunction | None | Failure to Advance |
| 2016-12-23 | Malfunction | None | Material Rupture |
| 2016-12-22 | Malfunction | None | Material Rupture |
| 2016-12-21 | Malfunction | None | Bent |
| 2016-12-15 | Malfunction | None | Failure to Advance |
| 2016-12-09 | Malfunction | None | Material Rupture |
| 2016-12-08 | Malfunction | None | Failure to Advance |
| 2016-12-06 | Malfunction | None | Break |
| 2016-12-05 | Malfunction | None | Break |
| 2016-12-05 | Malfunction | None | Failure to Advance |
| 2016-12-01 | Malfunction | None | Failure to Advance |
| 2016-11-30 | Malfunction | None | Material Rupture |
| 2016-11-29 | Malfunction | None | Hole In Material |
| 2016-11-29 | Malfunction | None | Break |
| 2016-11-26 | Injury | None | Material Rupture |
| 2016-11-25 | Malfunction | None | Failure to Advance |
| 2016-11-24 | Malfunction | None | Difficult to Advance, Material Deformation |
| 2016-11-23 | Malfunction | None | Material Rupture |
| 2016-11-22 | Malfunction | None | Material Rupture |
| 2016-11-16 | Malfunction | None | Material Rupture |
| 2016-11-16 | Malfunction | None | Break, Device Damaged Prior to Use |
| 2016-11-16 | Malfunction | None | Break |
| 2016-11-11 | Malfunction | None | Kinked |
| 2016-11-11 | Malfunction | None | Break |
| 2016-11-07 | Malfunction | None | Failure to Advance |
| 2016-10-28 | Malfunction | None | Failure to Advance |
| 2016-10-27 | Malfunction | None | Kinked |
| 2016-10-21 | Malfunction | None | Material Rupture |
| 2016-10-21 | Injury | None | Material Rupture |
| 2016-10-21 | Malfunction | None | Fracture |
| 2016-10-14 | Malfunction | None | Kinked |
| 2016-10-09 | Malfunction | None | Break |
| 2016-10-08 | Malfunction | None | Failure to Advance |
| 2016-09-22 | Malfunction | None | Kinked |
| 2016-09-19 | Malfunction | None | Failure to Advance |
| 2016-09-16 | Injury | None | Break |
| 2016-09-14 | Malfunction | None | Material Rupture |
| 2016-08-27 | Malfunction | None | Break |
| 2016-08-25 | Malfunction | None | Kinked |
| 2016-08-18 | Malfunction | None | Material Rupture |
| 2016-08-15 | Malfunction | None | Failure to Advance |
| 2016-08-13 | Malfunction | None | Failure to Advance |
| 2016-08-09 | Malfunction | None | Failure to Advance |
| 2016-08-03 | Malfunction | None | Failure to Advance |
| 2016-08-02 | Malfunction | None | Material Rupture |
| 2016-07-22 | Malfunction | None | Material Rupture |
| 2016-07-22 | Malfunction | None | Material Rupture |
| 2016-07-20 | Malfunction | None | Failure to Advance |
| 2016-07-20 | Malfunction | None | Failure to Advance |
| 2016-07-13 | Malfunction | None | Material Rupture |
| 2016-07-12 | Malfunction | None | Failure to Advance |
| 2016-07-08 | Malfunction | None | Failure to Advance |
| 2016-07-05 | Malfunction | None | Failure to Advance |
| 2016-07-02 | Malfunction | None | Inflation Problem |
| 2016-06-27 | Malfunction | None | Failure to Advance |
| 2016-06-23 | Malfunction | None | Break, Device Damaged Prior to Use |
| 2016-06-22 | Malfunction | None | Failure to Advance |
| 2016-06-15 | Malfunction | None | Kinked |
| 2016-06-12 | Malfunction | None | Failure to Advance |
| 2016-06-12 | Malfunction | None | Failure to Advance |
| 2016-06-12 | Malfunction | None | Failure to Advance |
| 2016-06-01 | Malfunction | None | Failure to Advance |
| 2016-05-30 | Malfunction | None | Failure to Advance |
| 2014-06-24 | Malfunction | None | Break |
| 2013-12-25 | Malfunction | None | Fracture |
| 2013-05-01 | Malfunction | None | None |
| 2013-04-24 | Malfunction | Insufficient Information | Impedance Problem |
| 2013-04-24 | Malfunction | Insufficient Information | Low impedance |
| 2013-04-16 | Malfunction | None | None |
| 2013-04-01 | Malfunction | None | None |
| 2013-03-06 | Malfunction | None | None |
| 2013-02-19 | Malfunction | None | None |
| 2013-02-16 | Malfunction | None | None |
| 2013-01-21 | Malfunction | None | None |
| 2013-01-15 | Malfunction | None | None |
| 2013-01-14 | Malfunction | None | None |
| 2013-01-14 | Malfunction | None | None |
| 2012-12-24 | Malfunction | None | None |
| 2012-11-21 | Malfunction | None | None |
| 2012-11-20 | Malfunction | None | None |
| 2012-11-16 | Malfunction | None | None |
| 2012-11-13 | Malfunction | None | None |
| 2012-11-08 | Malfunction | None | None |
| 2012-11-06 | Malfunction | None | None |
| 2012-11-06 | Malfunction | None | None |
| 2012-10-24 | Malfunction | None | None |
| 2012-10-19 | Malfunction | None | None |
| 2012-10-11 | Malfunction | None | None |
| 2012-10-03 | Malfunction | None | None |
| 2012-09-10 | Malfunction | None | None |
| 2012-08-31 | Malfunction | None | None |
| 2012-08-31 | Malfunction | None | None |
| 2012-08-28 | Malfunction | None | None |
| 2012-08-23 | Malfunction | None | None |
| 2012-08-16 | Malfunction | None | None |
| 2012-08-13 | Malfunction | None | None |
| 2012-08-07 | Malfunction | None | None |
| 2012-08-01 | Malfunction | None | None |
| 2012-07-22 | Malfunction | None | None |
| 2012-07-20 | Malfunction | None | None |
| 2012-07-18 | Malfunction | None | None |
| 2012-07-14 | Malfunction | None | None |
| 2012-07-09 | Malfunction | None | None |
| 2012-07-09 | Malfunction | None | None |
| 2012-07-07 | Malfunction | None | None |
| 2012-07-07 | Malfunction | None | None |
| 2012-07-06 | Malfunction | None | None |
| 2012-06-26 | Malfunction | None | None |
| 2012-06-19 | Malfunction | None | None |
| 2012-06-15 | Malfunction | None | None |
| 2012-06-06 | Malfunction | None | None |
| 2012-05-30 | Malfunction | None | None |
| 2012-05-29 | Malfunction | None | None |
| 2012-05-24 | Malfunction | None | None |
| 2012-05-13 | Malfunction | None | None |
| 2012-05-10 | Injury | None | None |
| 2012-04-24 | Malfunction | None | None |
| 2012-03-27 | Malfunction | None | None |
| 2012-03-12 | Malfunction | None | None |
| 2012-02-28 | Malfunction | None | None |
| 2012-02-17 | Malfunction | None | None |
| 2012-02-14 | Malfunction | None | None |
| 2012-02-06 | Malfunction | None | None |
| 2012-01-27 | Malfunction | None | None |
| 2012-01-26 | Malfunction | None | None |
| 2011-12-26 | Malfunction | None | None |
| 2011-07-15 | Malfunction | None | None |
| 2011-06-17 | Malfunction | None | None |
| 2011-05-26 | Malfunction | None | None |
| 2011-05-23 | Malfunction | None | None |
| 2011-04-28 | Malfunction | None | None |
| 2011-04-26 | Malfunction | None | None |
| 2011-04-20 | Malfunction | None | None |
| 2011-04-15 | Malfunction | None | None |
| 2011-04-13 | Malfunction | None | None |
| 2011-03-31 | Malfunction | None | None |
| 2011-03-31 | Malfunction | None | None |
| 2011-03-30 | Malfunction | None | None |
| 2011-03-22 | Malfunction | None | None |
| 2011-03-09 | Malfunction | None | None |
| 2011-03-07 | Malfunction | None | None |
| 2011-03-05 | Malfunction | None | None |
| 2011-03-02 | Injury | None | None |
| 2011-02-24 | Malfunction | None | None |
| 2011-02-21 | Malfunction | None | None |
| 2011-02-18 | Malfunction | None | None |
| 2011-02-18 | Malfunction | None | None |
| 2011-02-10 | Malfunction | None | None |
| 2011-02-08 | Malfunction | None | None |
| 2011-02-01 | Malfunction | None | None |
| 2011-02-01 | Malfunction | None | None |
| 2011-01-28 | Malfunction | None | None |
| 2011-01-21 | Malfunction | None | None |
| 2011-01-17 | Malfunction | None | None |
| 2011-01-17 | Malfunction | None | None |
| 2011-01-06 | Malfunction | None | None |
| 2010-12-28 | Malfunction | None | None |
| 2010-12-14 | Malfunction | None | None |
| 2010-12-10 | Malfunction | None | None |
| 2010-12-07 | Malfunction | None | None |
| 2010-12-07 | Malfunction | None | None |
| 2010-12-03 | Malfunction | None | None |
| 2010-12-03 | Malfunction | None | None |
| 2010-11-18 | Malfunction | None | None |
| 2010-11-16 | Malfunction | None | None |
| 2010-11-16 | Malfunction | None | None |
| 2010-11-08 | Malfunction | None | None |
| 2010-11-07 | Malfunction | None | None |
| 2010-11-01 | Malfunction | None | None |
| 2010-10-25 | Malfunction | None | None |
| 2010-10-25 | Malfunction | None | None |
| 2010-10-21 | Malfunction | None | None |
| 2010-10-19 | Malfunction | None | None |
| 2010-10-13 | Malfunction | None | None |
| 2010-10-05 | Malfunction | None | None |
| 2010-10-05 | Malfunction | None | None |
| 2010-10-01 | Malfunction | None | None |
| 2010-09-29 | Malfunction | None | None |
| 2010-09-19 | Malfunction | None | None |
| 2010-09-15 | Malfunction | None | None |
| 2010-09-15 | Malfunction | None | None |
| 2010-09-14 | Malfunction | None | None |
| 2010-09-09 | Malfunction | None | None |
| 2010-09-09 | Death | None | None |
| 2010-09-09 | Malfunction | None | None |
| 2010-09-04 | Malfunction | None | None |
| 2010-08-27 | Malfunction | None | None |
| 2010-08-26 | Malfunction | None | None |
| 2010-08-25 | Malfunction | None | None |
| 2010-08-25 | Malfunction | None | None |
| 2010-08-24 | Malfunction | None | None |
| 2010-08-20 | Malfunction | None | None |
| 2010-08-18 | Injury | None | None |
| 2010-08-16 | Malfunction | None | None |
| 2010-08-13 | Malfunction | None | None |
| 2010-08-13 | Malfunction | None | None |
| 2010-08-06 | Malfunction | None | None |
| 2010-08-05 | Malfunction | None | None |
| 2010-08-02 | Malfunction | None | None |
| 2010-07-30 | Malfunction | None | None |
| 2010-07-28 | Malfunction | None | None |
| 2010-07-28 | Malfunction | None | None |
| 2010-07-28 | Malfunction | None | None |
| 2010-07-27 | Malfunction | None | None |
| 2010-07-27 | Malfunction | None | None |
| 2010-07-22 | Malfunction | None | None |
| 2010-07-21 | Malfunction | None | None |
| 2010-07-20 | Malfunction | None | None |
| 2010-07-20 | Malfunction | None | None |
| 2010-07-15 | Malfunction | None | None |
| 2010-07-14 | Malfunction | None | None |
| 2010-07-12 | Malfunction | None | None |
| 2010-07-07 | Malfunction | None | None |
| 2010-06-29 | Malfunction | None | None |
| 2010-06-29 | Malfunction | None | None |
| 2010-06-28 | Malfunction | None | None |
| 2010-06-28 | Malfunction | None | None |
| 2010-06-24 | Malfunction | None | None |
| 2010-06-23 | Malfunction | None | None |
| 2010-06-16 | Malfunction | None | None |
| 2010-06-15 | Malfunction | None | None |
| 2010-06-11 | Malfunction | None | None |
| 2010-06-11 | Malfunction | None | None |
| 2010-06-07 | Malfunction | None | None |
| 2010-06-03 | Malfunction | None | None |
| 2010-06-03 | Malfunction | None | None |
| 2010-05-25 | Injury | None | None |
| 2010-05-21 | Malfunction | None | None |
| 2010-05-21 | Malfunction | None | None |
| 2010-05-21 | Malfunction | None | None |
| 2010-05-19 | Injury | None | None |
| 2010-05-19 | Malfunction | None | None |
| 2010-05-18 | Malfunction | None | None |
| 2010-05-18 | Malfunction | None | None |
| 2010-05-18 | Injury | None | None |
| 2010-05-11 | Malfunction | None | None |
| 2010-05-11 | Malfunction | None | None |
| 2010-05-07 | Malfunction | None | None |
| 2010-04-26 | Malfunction | None | None |
| 2010-04-23 | Malfunction | None | None |
| 2010-04-22 | Malfunction | None | None |
| 2010-04-21 | Malfunction | None | None |
| 2010-04-14 | Malfunction | None | None |
| 2010-04-12 | Malfunction | None | None |
| 2010-04-12 | Malfunction | None | None |
| 2010-04-12 | Malfunction | None | None |
| 2010-04-07 | Malfunction | None | None |
| 2010-04-07 | Injury | None | None |
| 2010-04-06 | Malfunction | None | None |
| 2010-04-02 | Malfunction | None | None |
| 2010-03-30 | Malfunction | None | None |
| 2010-03-26 | Malfunction | None | None |
| 2010-03-23 | Malfunction | None | None |
| 2010-03-22 | Malfunction | None | None |
| 2010-03-18 | Injury | None | None |
| 2010-03-15 | Malfunction | None | None |
| 2010-03-12 | Malfunction | None | None |
| 2010-03-09 | Malfunction | None | None |
| 2010-03-08 | Malfunction | None | None |
| 2010-03-08 | Malfunction | None | None |
| 2010-03-03 | Malfunction | None | None |
| 2010-03-02 | Malfunction | None | None |
| 2010-03-01 | Malfunction | None | None |
| 2010-03-01 | Injury | None | None |
| 2010-02-24 | Malfunction | None | None |
| 2010-02-19 | Malfunction | None | None |
| 2010-02-18 | Malfunction | None | None |
| 2010-02-15 | Malfunction | None | None |
| 2010-02-10 | Malfunction | None | None |
| 2010-02-07 | Injury | None | None |
| 2010-02-04 | Malfunction | None | None |
| 2010-01-29 | Malfunction | None | None |
| 2010-01-25 | Malfunction | None | None |
| 2010-01-22 | Malfunction | None | None |
| 2010-01-19 | Malfunction | None | None |
| 2010-01-19 | Malfunction | None | None |
| 2010-01-18 | Malfunction | None | None |
| 2010-01-14 | Malfunction | None | None |
| 2010-01-14 | Malfunction | None | None |
| 2010-01-14 | Malfunction | None | None |
| 2010-01-14 | Malfunction | None | None |
| 2010-01-11 | Malfunction | None | None |
| 2010-01-07 | Injury | None | None |
| 2010-01-05 | Malfunction | None | None |
| 2010-01-02 | Malfunction | None | None |
| 2009-05-21 | Injury | None | None |
| 2009-05-09 | Death | None | None |
| 2008-07-31 | Injury | None | None |