MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-17 for SENTINEL CMS15-10C-US manufactured by Claret Medical, Inc..
[175395469]
A boston scientific/abbott/claret medical sentinel neuro protection device was being used for a tavr. The device was kinked coming out of the package and unusable. The device was replaced with a new device and used without difficulty. No known injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9601196 |
| MDR Report Key | 9601196 |
| Date Received | 2020-01-17 |
| Date of Report | 2019-11-21 |
| Date of Event | 2019-10-09 |
| Report Date | 2019-12-31 |
| Date Reported to FDA | 2019-12-31 |
| Date Reported to Mfgr | 2020-01-17 |
| Date Added to Maude | 2020-01-17 |
| 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 | RISK MANAGER |
| 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 |
| Generic Name | TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES |
| Product Code | PUM |
| Date Received | 2020-01-17 |
| Model Number | CMS15-10C-US |
| Catalog Number | CMS15-10C-US |
| Lot Number | 19H15H33 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLARET MEDICAL, INC. |
| Manufacturer Address | 1745 COPPERHILL PKWY SANTA ROSA CA 95403 US 95403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-17 |