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 2020-03-27 for WATCHMAN TRUSEAL ACCESS SYSTEM M635TU70040 manufactured by Boston Scientific Corporation.
[185662953]
It was reported the access system was damaged/defective. A left atrial appendage (laa) closure procedure was being performed. A watchman truseal access system (was) was positioned and a 27mm watchman laa closure device & delivery system (wds) were used. After entering the patient's body, the was was found to be kinked and also damaged the 27mm wds. Both the wds and was were removed and a new was and wds were prepped. After prepping the second was and wds, inserting the system as a whole into the patients body, and successfully deploying the second 27 mm device, it was noted that it seemed that something was hanging off the sheath in the left atrium. More heparin was given as thrombus formation was suspected; however, the heparin did not mitigate the issue. The 27mm device was released after going through pass criteria per dfu and the whole system was removed. Upon removal of the sheath, it was noted that a fiber-like strand was hanging off the end of the sheath. No harm was done to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03795 |
| MDR Report Key | 9889436 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-06-28 |
| Date Added to Maude | 2020-03-27 |
| 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 TRUSEAL ACCESS SYSTEM |
| Generic Name | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL |
| Product Code | DQY |
| Date Received | 2020-03-27 |
| Model Number | M635TU70040 |
| Catalog Number | M635TU70040 |
| Lot Number | 0024033040 |
| 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 | 2020-03-27 |