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 2020-03-17 for WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM 10371 manufactured by Boston Scientific Corporation.
[183919177]
It was reported a pericardial effusion occurred. A left atrial appendage (laa) closure procedure was performed. A watchman access system (was) and 24mm watchman laa closure device and delivery system (wds) were used. The trans-septal puncture was performed and the was was positioned in the distal aspect of the laa. The wds was inserted into the was and napped together. The closure device was deployed, but it was too proximal, so it was fully recaptured. Another 24mm wds was used. This closure device was deployed and met release criteria, so it was successfully implanted. The patient's hemodynamics were stable with no signs of distress throughout the procedure. The patient was sent to recovery. One day post procedure, the patient complained of chest pain and discomfort. A transthoracic echocardiogram (tte) was performed and a small pericardial effusion was noted. They monitored the patient overnight. The following day, the patient still had chest discomfort, so a pericardiocentesis was performed. 300ml of fluid was removed. The patient tolerated it well and has since been discharged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03449 |
| MDR Report Key | 9843415 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-12-19 |
| Date Added to Maude | 2020-03-17 |
| 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 | 2020-03-17 |
| Model Number | 10371 |
| Catalog Number | 10371 |
| Lot Number | 0024954959 |
| 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 | 2020-03-17 |