MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for SENTINEL CEREBRAL PROTECTION DEVICE CMS15-10C-US manufactured by Boston Scientific Corporation.
[184265779]
During transcath aortic valve replacement percutaneous approach, a sentinel cerebral protection device leaked at the pressure port. A new replacement device was used instead and so no impact to patient. The device was saved and was picked up by the boston sci representative for return to boston sci for inspection of device that failed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9859583 |
| MDR Report Key | 9859583 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-25 |
| Report Date | 2020-03-10 |
| Date Reported to FDA | 2020-03-10 |
| Date Reported to Mfgr | 2020-03-20 |
| Date Added to Maude | 2020-03-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENTINEL CEREBRAL PROTECTION DEVICE |
| Generic Name | TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES |
| Product Code | PUM |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-04 |
| Model Number | CMS15-10C-US |
| Catalog Number | CMS15-10C-US |
| Lot Number | 25086338 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 1745 COPPERHILL PKWY SANTA ROSA CA 95403 US 95403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |