MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-26 for WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM manufactured by Boston Scientific Corporation.
[187708079]
Event date was unknown so it was estimated.
Patient Sequence No: 1, Text Type: N, H10
[187708080]
It was reported that there was a perforation and that the patient experienced a cardiac arrest. It was reported via social media that during a left atrial appendage (laa) closure procedure involving a watchman device, the physician perforated the patients heart which required surgery and blood transfusions to repair. The patient also went into cardiac arrest, and received cpr before they recovered from this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03742 |
| MDR Report Key | 9886493 |
| Report Source | CONSUMER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-26 |
| 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 LAA CLOSURE DEVICE & DELIVERY SYSTEM |
| Generic Name | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL |
| Product Code | NGV |
| Date Received | 2020-03-26 |
| 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 | 2020-03-26 |