WATCHMAN TRUSEAL ACCESS SYSTEM Adverse Event — Malfunction (MDR 2134265-2020-05684)
WATCHMAN TRUSEAL ACCESS SYSTEM Adverse Event — Malfunction (MDR 2134265-2020-05684) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: WATCHMAN TRUSEAL ACCESS SYSTEM; Generic name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | WATCHMAN TRUSEAL ACCESS SYSTEM |
|---|---|
| Generic name | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05684 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO RECAPTURE. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN TRUSEAL ACCESS SYSTEM (WAS) WAS POSITIONED AND A WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE USED. WHEN THE SHOULDER PART OF THE WDS CAME OUT FROM THE SHEATH, SEVERE RESISTANCE WAS FELT, AND THE CLOSURE DEVICE WAS DEPLOYED TOO PROXIMAL. THE WDS WA |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →