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 2020-03-18 for WATCHMAN ACCESS SYSTEM 10373 manufactured by Boston Scientific Corporation.
[183954033]
It was reported that a pericardial effusion occurred. A left atrial appendage (laa) closure procedure was being performed. The physician gained transseptal access, the transseptal sheath was removed and then the watchman access system (was) was inserted and advanced into the left atrium. The physician then lost the transseptal access with the sheath. After losing access, fluid was noted to be in the pericardial space. The patients blood pressure dropped and a pericardiocentesis was performed to treat the pericardial effusion. Fluid was drained from the patient and the drain was kept in place. The patients blood pressure then stabilized and the effusion was minimized. The physician reversed the heparin and the procedure was ended following this. The patient was awake and doing well in the hospital the next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02645 |
| MDR Report Key | 9848898 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-11-04 |
| Date Added to Maude | 2020-03-18 |
| 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 ACCESS SYSTEM |
| Generic Name | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL |
| Product Code | NGV |
| Date Received | 2020-03-18 |
| Model Number | 10373 |
| Catalog Number | 10373 |
| Lot Number | 0024705181 |
| 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 | 2020-03-18 |