MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for WATCHMAN TRUSEAL ACCESS SYSTEM UNK manufactured by Boston Scientific Corporation.
[186752049]
It was reported that a perforation and a pericardial effusion occurred. A left atrial appendage (laa) closure procedure was being performed. A watchman access system (was) was repositioned for a better trajectory into the appendage after the first device landed too proximal. As they were advancing the second delivery system, the was noted to be outside of the appendage via fluoroscopy. A contrast shot was performed and a small effusion on echo was confirmed. The effusion and blood pressure of the patient remained unchanged. Once the device was unsheathed, the blood pressure and effusion became worse. A pericardiocentesis was performed but blood removal proved ineffective so the patient was sent to surgery for repair of the perforation and laa closure. The patient was stable and was discharged home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03873 |
| MDR Report Key | 9890440 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-10-21 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATCHMAN TRUSEAL ACCESS SYSTEM |
| Generic Name | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL |
| Product Code | DQY |
| Date Received | 2020-03-27 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 0024628098 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |