MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-09 for SENTINEL CEREBRAL PROTECTION SYSTEM CMS15-10C-US manufactured by Claret Medical.
[141574173]
Claret medical, sentinel cerebral protection system, would not bend near the tip of the catheter to allow for navigation. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085711 |
| MDR Report Key | 8499859 |
| Date Received | 2019-04-09 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-04-05 |
| Date Added to Maude | 2019-04-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | SENTINEL CEREBRAL PROTECTION SYSTEM |
| Generic Name | TEMPORARY CATHETER, EMBOLIC PROTECTION TRANSCATHETER INTRACARDIAC PROCEDURES |
| Product Code | PUM |
| Date Received | 2019-04-09 |
| Model Number | CMS15-10C-US |
| Catalog Number | CMS15-10C-US |
| Lot Number | 19B25H20 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CLARET MEDICAL |
| Manufacturer Address | SANTA ROSA CA 95403 US 95403 |
| Brand Name | SENTINEL CEREBRAL PROTECTION SYSTEM |
| Generic Name | TEMPORARY CATHETER, EMBOLIC PROTECTION TRANSCATHETER INTRACARDIAC PROCEDURES |
| Product Code | PUM |
| Date Received | 2019-04-09 |
| Model Number | CMS15-10C-US |
| Catalog Number | CMS15-10C-US |
| Lot Number | 19B25H20 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLARET MEDICAL |
| Manufacturer Address | SANTA ROSA CA 95403 US 95403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-09 |