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.
[184163409]
It was reported that an effusion and cardiac tamponade occurred. A left atrial appendage (laa) closure procedure was being performed. A 30mm watchman laa closure device was deployed but not released. Three partial recaptures were done; however, after the third partial recapture the patient's vital signs became unstable. They swept for an effusion which was confirmed and the patient developed cardiac tamponade. A pericardiocentesis was urgently performed. The patient stabilized after being given protamine but declined shortly after. A ventricular support device was placed in the right and left side of the heart. Cpr and defibrillation was required. A large clot formed in the pericardial sac which required a subxiphoid incision and two drains inserted into the pericardium. There was still flow noted leaving the appendage by tee. A sternotomy was performed and two atrial clips were placed on the appendage to stop the bleeding. The patient stabilized and the chest was closed. The laa closure procedure was not completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02882 |
| MDR Report Key | 9856548 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-04-10 |
| 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 | 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 | 2020-03-19 |
| Model Number | 10371 |
| Catalog Number | 10371 |
| Lot Number | 0023625712 |
| 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 | 2020-03-19 |