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 2020-03-19 for WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM 10371 manufactured by Boston Scientific Corporation.
[184179417]
It was reported that a patient death occurred. A left atrial appendage (laa) closure procedure was being performed. A watchman access system (was) was positioned and a 24mm watchman laa closure device & delivery system (wds) were used. The closure device was deployed in the laa, but did not meet release criteria. The closure device was fully recaptured and at this time it was noted that the patient had a pericardial effusion. The patients heart rate started to change and the patient became hemodynamically unstable. The physician then used a 27mm watchman laa closure device. They deployed the closure device, but the patient was becoming increasingly unstable. They tried to perform a pericardial tap, but they were having a hard time getting access to the effusion. The patient went in to ventricular tachycardia, was shocked multiple times and then they coded. The patient did not recover from the code and passed away. They opened up the patient's chest and saw that the effusion originated from the right side. The right atrial appendage had a hole so they were not sure when the effusion actually occurred. They suspected it happened during the trans-septal puncture since that was difficult, but it was not noticed until the full recapture of the 24mm closure device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03386 |
| MDR Report Key | 9857214 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-07-10 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2020-03-19 |
| Model Number | 10371 |
| Catalog Number | 10371 |
| Lot Number | 0024086586 |
| 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. Death | 2020-03-19 |