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 Tissue Injury | 1 | Patient |
| 2024 | Thrombosis/Thrombus | 2 | Patient |
| 2024 | Stroke/CVA | 1 | Patient |
| 2024 | Pericardial Effusion | 2 | Patient |
| 2024 | Cardiac Tamponade | 1 | Patient |
| 2024 | Material Integrity Problem | 2 | Device |
| 2024 | Material Deformation | 3 | Device |
| 2024 | Difficult to Remove | 4 | Device |
| 2024 | Difficult to Open or Close | 5 | Device |
| 2024 | Device Dislodged or Dislocated | 2 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2023 | Thrombosis/Thrombus | 5 | Patient |
| 2023 | Stroke/CVA | 3 | Patient |
| 2023 | Pericardial Effusion | 1 | Patient |
| 2023 | Obstruction/Occlusion | 1 | Patient |
| 2023 | Chest Pain | 2 | Patient |
| 2023 | Air Embolism | 1 | Patient |
| 2023 | Material Integrity Problem | 6 | Device |
| 2023 | Material Deformation | 3 | Device |
| 2023 | Difficult to Remove | 4 | Device |
| 2023 | Difficult to Open or Close | 1 | Device |
| 2023 | Difficult to Flush | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 11 | Device |
| 2022 | Thrombosis/Thrombus | 1 | Patient |
| 2022 | Stroke/CVA | 1 | Patient |
| 2022 | Pericardial Effusion | 2 | Patient |
| 2022 | Cardiac Tamponade | 1 | Patient |
| 2022 | Cardiac Perforation | 1 | Patient |
| 2022 | Material Integrity Problem | 2 | Device |
| 2022 | Material Deformation | 1 | Device |
| 2022 | Difficult to Remove | 6 | Device |
| 2022 | Device Dislodged or Dislocated | 4 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2021 | Stroke/CVA | 1 | Patient |
| 2021 | Pericardial Effusion | 1 | Patient |
| 2021 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2021 | Cardiac Tamponade | 1 | Patient |
| 2021 | Cardiac Perforation | 1 | Patient |
| 2021 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2020 | Transient Ischemic Attack | 1 | Patient |
| 2020 | Thrombosis/Thrombus | 2 | Patient |
| 2020 | Tachycardia | 1 | Patient |
| 2020 | Myocardial Infarction | 1 | Patient |
| 2020 | High Blood Pressure/ Hypertension | 1 | Patient |
| 2020 | Dyspnea | 1 | Patient |
| 2020 | Migration | 1 | Device |
| 2020 | Difficult to Open or Close | 2 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2019 | Thrombosis/Thrombus | 4 | Patient |
| 2019 | Stroke/CVA | 2 | Patient |
| 2019 | Pulmonary Embolism | 1 | Patient |
| 2019 | Pericardial Effusion | 1 | Patient |
| 2019 | Malaise | 1 | Patient |
| 2019 | Fistula | 1 | Patient |
| 2019 | Fever | 1 | Patient |
| 2019 | Cardiac Tamponade | 1 | Patient |
| 2019 | Cardiac Perforation | 1 | Patient |
| 2019 | Bacterial Infection | 1 | Patient |
| 2019 | Physical Resistance/Sticking | 2 | Device |
| 2019 | Migration | 10 | Device |
| 2019 | Material Integrity Problem | 5 | Device |
| 2019 | Material Deformation | 6 | Device |
| 2019 | Leak/Splash | 1 | Device |
| 2019 | Gas/Air Leak | 4 | Device |
| 2019 | Difficult to Remove | 13 | Device |
| 2019 | Difficult to Open or Close | 4 | Device |
| 2019 | Difficult or Delayed Positioning | 2 | Device |
| 2019 | Device Dislodged or Dislocated | 24 | Device |
| 2019 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2019 | Detachment of Device or Device Component | 4 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 263 | Device |
| 2018 | Premature Activation | 1 | Device |
| 2018 | Positioning Problem | 2 | Device |
| 2018 | Migration | 3 | Device |
| 2018 | Material Twisted/Bent | 1 | Device |
| 2018 | Material Integrity Problem | 5 | Device |
| 2018 | Material Deformation | 1 | Device |
| 2018 | Leak/Splash | 1 | Device |
| 2018 | Gas/Air Leak | 4 | Device |
| 2018 | Difficult to Remove | 13 | Device |
| 2018 | Difficult to Open or Close | 3 | Device |
| 2018 | Device-Device Incompatibility | 1 | Device |
| 2018 | Device Dislodged or Dislocated | 11 | Device |
| 2018 | Detachment of Device or Device Component | 5 | Device |
| 2018 | Air Leak | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 159 | Device |
| 2018 | Activation, Positioning or Separation Problem | 1 | Device |
| 2017 | Occlusion Within Device | 1 | Device |
| 2017 | Insufficient Information | 5 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2016 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2016 | Cardiac Perforation | 1 | Patient |
| 2016 | Occlusion Within Device | 1 | Device |
| 2016 | Insufficient Information | 2 | Device |
| 2016 | Device Operates Differently Than Expected | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2014 | Transient Ischemic Attack | 1 | Patient |
| 2014 | Thrombosis/Thrombus | 2 | Patient |
| 2014 | Cardiac Tamponade | 1 | Patient |
| 2014 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2012 | Thrombosis/Thrombus | 17 | Patient |
| 2012 | Thromboembolism | 1 | Patient |
| 2012 | Difficult to Open or Close | 1 | Device |
| 2012 | Adverse Event Without Identified Device or Use Problem | 17 | Device |