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 2020-01-27 for SENTINEL CEREBRAL PROTECTION SYSTEM (US) CMS15-10C-US manufactured by Claret Medical, Inc..
[178389106]
It was reported that proximal filter didn't retract. A sentinel cerebral protection system was successfully used for a procedure. During removal of the device, the number one slider was unable to resheath the proximal filter. The physician attempted to retract the slider several times without success. The distal filter was fully resheathed without issue. The sentinel device was removed with the proximal filter out. No patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-00474 |
| MDR Report Key | 9633445 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-27 |
| Date of Event | 2019-12-15 |
| Date Mfgr Received | 2020-01-10 |
| Date Added to Maude | 2020-01-27 |
| 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 | CLARET MANUFACTURING |
| Manufacturer Street | 1745 COPPERHILL PARKWAY |
| Manufacturer City | SANTA ROSA CA 95403 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95403 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENTINEL CEREBRAL PROTECTION SYSTEM (US) |
| Generic Name | EMBOLIC PROTECTION DEVICE |
| Product Code | PUM |
| Date Received | 2020-01-27 |
| Model Number | CMS15-10C-US |
| Catalog Number | CMS15-10C-US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLARET MEDICAL, INC. |
| Manufacturer Address | 1745 COPPERHILL PARKWAY SANTA ROSA CA 95403 US 95403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-27 |