MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-20 for WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM 10365 manufactured by Boston Scientific Corporation.
[184536548]
It was reported that a pericardial effusion occurred. A left atrial appendage (laa) closure procedure was being performed. A watchman access system (was) was positioned and a 33mm watchman laa closure device & delivery system (wds) were used. The closure device was deployed in the laa of the patient, but did not meet release criteria and needed to be fully recaptured. During the recapture an echo image showed that the laa tissue was being pulled on by the closure device. The closure device feet were caught on the mitral side pectinate. The physician slightly deployed the device and the tissue was released. The device was pulled toward the left atrium and was fully recaptured and removed from the patient. The patient had physiological pericardial effusion, but no increase in pericardial effusion after recapture. After that, a new 33mm device was deployed, but severe resistance was felt when deploying the device, and it became too proximal. This device was fully recaptured and removed from the patient. The third 33mm device was successfully implanted in the laa of the patient. There was no increase in pericardial effusion observed when the effusion check was performed after completing the procedure. The patient was doing fine and no other complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03530 |
| MDR Report Key | 9860819 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-03-08 |
| Date Added to Maude | 2020-03-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-20 |
| Returned To Mfg | 2020-03-16 |
| Model Number | 10365 |
| Catalog Number | 10365 |
| Lot Number | 0023460337 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-20 |