SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
This device is manufactured by BOSTON SCIENTIFIC CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Thrombosis/Thrombus | 2 | Patient |
| 2024 | Retroperitoneal Hemorrhage | 4 | Patient |
| 2024 | Pseudoaneurysm | 5 | Patient |
| 2024 | Pericardial Effusion | 3 | Patient |
| 2024 | Perforation of Vessels | 4 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 6 | Patient |
| 2024 | Hemoptysis | 1 | Patient |
| 2024 | Hematoma | 6 | Patient |
| 2024 | Cardiac Tamponade | 1 | Patient |
| 2024 | Cardiac Perforation | 1 | Patient |
| 2024 | Cardiac Arrest | 2 | Patient |
| 2024 | Material Integrity Problem | 2 | Device |
| 2024 | Material Deformation | 11 | Device |
| 2024 | Leak/Splash | 2 | Device |
| 2024 | Air/Gas in Device | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 40 | Device |
| 2023 | Unspecified Tissue Injury | 1 | Patient |
| 2023 | Pericardial Effusion | 2 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 3 | Patient |
| 2023 | Cardiac Perforation | 1 | Patient |
| 2023 | Air Embolism | 1 | Patient |
| 2023 | Material Integrity Problem | 3 | Device |
| 2023 | Material Deformation | 16 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2022 | Material Integrity Problem | 2 | Device |
| 2022 | Material Deformation | 12 | Device |
| 2022 | Leak/Splash | 1 | Device |
| 2022 | Gas/Air Leak | 1 | Device |
| 2022 | Difficult to Advance | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2021 | Material Integrity Problem | 1 | Device |