SUTURE MEDIATED CLOSURE
This device is manufactured by ABBOTT MEDICA / ABBOTT VASCULAR, ABBOTT MEDICAL, ABBOTT VASCULAR.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Vascular Dissection | 3 | Patient |
| 2024 | Unspecified Tissue Injury | 13 | Patient |
| 2024 | Unspecified Infection | 2 | Patient |
| 2024 | Swelling/ Edema | 2 | Patient |
| 2024 | Shock | 2 | Patient |
| 2024 | Pseudoaneurysm | 2 | Patient |
| 2024 | Pain | 4 | Patient |
| 2024 | Obstruction/Occlusion | 9 | Patient |
| 2024 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2024 | Ischemia | 1 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 6 | Patient |
| 2024 | Hematoma | 1 | Patient |
| 2024 | Great Vessel Perforation | 1 | Patient |
| 2024 | Foreign Body In Patient | 3 | Patient |
| 2024 | Device Embedded In Tissue or Plaque | 1 | Patient |
| 2024 | Cardiogenic Shock | 1 | Patient |
| 2024 | Cardiac Arrest | 1 | Patient |
| 2024 | Unintended System Motion | 4 | Device |
| 2024 | Scratched Material | 1 | Device |
| 2024 | Retraction Problem | 2 | Device |
| 2024 | Product Quality Problem | 12 | Device |
| 2024 | Positioning Problem | 1 | Device |
| 2024 | Patient Device Interaction Problem | 6 | Device |
| 2024 | Off-Label Use | 48 | Device |
| 2024 | Obstruction of Flow | 24 | Device |
| 2024 | Noise, Audible | 4 | Device |
| 2024 | Mechanical Jam | 2 | Device |
| 2024 | Material Split, Cut or Torn | 2 | Device |
| 2024 | Material Separation | 108 | Device |
| 2024 | Malposition of Device | 20 | Device |
| 2024 | Leak/Splash | 1 | Device |
| 2024 | Insufficient Information | 17 | Device |
| 2024 | Improper or Incorrect Procedure or Method | 16 | Device |
| 2024 | Failure to Fire | 5 | Device |
| 2024 | Failure to Cycle | 903 | Device |
| 2024 | Failure to Advance | 5 | Device |
| 2024 | Entrapment of Device | 21 | Device |
| 2024 | Difficult to Remove | 20 | Device |
| 2024 | Difficult to Open or Close | 28 | Device |
| 2024 | Difficult to Insert | 6 | Device |
| 2024 | Difficult to Flush | 1 | Device |
| 2024 | Difficult to Advance | 7 | Device |
| 2024 | Difficult or Delayed Activation | 1 | Device |
| 2024 | Device Damaged by Another Device | 5 | Device |
| 2024 | Deformation Due to Compressive Stress | 6 | Device |
| 2024 | Break | 9 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2023 | Vascular Dissection | 2 | Patient |
| 2023 | Unspecified Tissue Injury | 20 | Patient |
| 2023 | Unspecified Infection | 2 | Patient |
| 2023 | Tissue Breakdown | 1 | Patient |
| 2023 | Thrombosis/Thrombus | 1 | Patient |
| 2023 | Swelling/ Edema | 2 | Patient |
| 2023 | Pseudoaneurysm | 3 | Patient |
| 2023 | Perforation of Vessels | 2 | Patient |
| 2023 | Pain | 1 | Patient |
| 2023 | Obstruction/Occlusion | 10 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Inflammation | 1 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 25 | Patient |
| 2023 | Hematoma | 8 | Patient |
| 2023 | Foreign Body In Patient | 5 | Patient |
| 2023 | Fever | 1 | Patient |
| 2023 | Device Embedded In Tissue or Plaque | 2 | Patient |
| 2023 | Unintended System Motion | 1 | Device |
| 2023 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2023 | Retraction Problem | 4 | Device |
| 2023 | Product Quality Problem | 9 | Device |
| 2023 | Positioning Problem | 2 | Device |
| 2023 | Physical Resistance/Sticking | 1 | Device |
| 2023 | Patient Device Interaction Problem | 15 | Device |
| 2023 | Output Problem | 1 | Device |
| 2023 | Off-Label Use | 76 | Device |
| 2023 | Obstruction of Flow | 26 | Device |
| 2023 | No Flow | 1 | Device |
| 2023 | Misfire | 2 | Device |
| 2023 | Mechanical Jam | 15 | Device |
| 2023 | Material Twisted/Bent | 1 | Device |
| 2023 | Material Split, Cut or Torn | 1 | Device |
| 2023 | Material Separation | 130 | Device |
| 2023 | Malposition of Device | 27 | Device |
| 2023 | Leak/Splash | 2 | Device |
| 2023 | Insufficient Information | 25 | Device |
| 2023 | Improper or Incorrect Procedure or Method | 54 | Device |
| 2023 | Fracture | 1 | Device |
| 2023 | Failure to Seal | 2 | Device |
| 2023 | Failure to Fire | 14 | Device |
| 2023 | Failure to Cycle | 1510 | Device |
| 2023 | Failure to Cut | 2 | Device |
| 2023 | Failure to Advance | 11 | Device |
| 2023 | Entrapment of Device | 36 | Device |
| 2023 | Difficult to Remove | 50 | Device |
| 2023 | Difficult to Open or Close | 66 | Device |
| 2023 | Difficult to Insert | 5 | Device |
| 2023 | Difficult to Flush | 1 | Device |
| 2023 | Difficult to Advance | 5 | Device |
| 2023 | Difficult or Delayed Activation | 4 | Device |
| 2023 | Device Damaged by Another Device | 2 | Device |
| 2023 | Detachment of Device or Device Component | 1 | Device |
| 2023 | Deformation Due to Compressive Stress | 3 | Device |
| 2023 | Connection Problem | 2 | Device |
| 2023 | Break | 6 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
| 2023 | Activation, Positioning or Separation Problem | 1 | Device |
| 2023 | Activation Problem | 3 | Device |
| 2023 | Accessory Incompatible | 2 | Device |
| 2022 | Vascular Dissection | 1 | Patient |
| 2022 | Unspecified Vascular Problem | 1 | Patient |
| 2022 | Unspecified Tissue Injury | 2 | Patient |
| 2022 | Thrombosis/Thrombus | 2 | Patient |
| 2022 | Swelling/ Edema | 1 | Patient |
| 2022 | Pseudoaneurysm | 1 | Patient |
| 2022 | Perforation of Vessels | 1 | Patient |
| 2022 | Pain | 2 | Patient |
| 2022 | Obstruction/Occlusion | 2 | Patient |
| 2022 | Ischemia | 1 | Patient |
| 2022 | Hypoxia | 1 | Patient |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2022 | Foreign Body In Patient | 1 | Patient |
| 2022 | Unintended System Motion | 3 | Device |
| 2022 | Separation Failure | 1 | Device |
| 2022 | Retraction Problem | 8 | Device |
| 2022 | Product Quality Problem | 7 | Device |
| 2022 | Positioning Problem | 3 | Device |
| 2022 | Peeled/Delaminated | 1 | Device |
| 2022 | Patient Device Interaction Problem | 27 | Device |
| 2022 | Off-Label Use | 48 | Device |
| 2022 | Obstruction of Flow | 17 | Device |
| 2022 | Noise, Audible | 1 | Device |
| 2022 | No Apparent Adverse Event | 2 | Device |
| 2022 | Mechanical Jam | 2 | Device |
| 2022 | Material Split, Cut or Torn | 2 | Device |
| 2022 | Material Separation | 92 | Device |
| 2022 | Malposition of Device | 16 | Device |
| 2022 | Leak/Splash | 2 | Device |
| 2022 | Insufficient Information | 5 | Device |
| 2022 | Improper or Incorrect Procedure or Method | 29 | Device |
| 2022 | Failure to Fire | 3 | Device |
| 2022 | Failure to Cycle | 601 | Device |
| 2022 | Failure to Advance | 2 | Device |
| 2022 | Entrapment of Device | 26 | Device |
| 2022 | Difficult to Remove | 24 | Device |
| 2022 | Difficult to Open or Close | 42 | Device |
| 2022 | Difficult to Insert | 10 | Device |
| 2022 | Difficult to Advance | 11 | Device |
| 2022 | Difficult or Delayed Activation | 1 | Device |
| 2022 | Device Damaged by Another Device | 4 | Device |
| 2022 | Deformation Due to Compressive Stress | 6 | Device |
| 2022 | Defective Device | 1 | Device |
| 2022 | Break | 9 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 5 | Device |