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 2020-01-10 for SENTINEL CEREBRAL PROTECTION SYSTEM (US) CMS15-10C-US manufactured by Claret Medical, Inc..
[178015092]
It was reported that the distal filter capture failure occurred. Procedure summary: a sentinel embolic protection device was placed and the filters deployed. When the physician attempted to recapture the distal filter, the handle broke and the filter could not be retrieved. The physician was able to retrieve the filter by using a clamp to pull on the hypotube. No patient complications were reported. The patient is fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-16692 |
| MDR Report Key | 9576100 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-10 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-03-12 |
| Date Added to Maude | 2020-01-10 |
| 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 MEDICAL, INC. |
| Manufacturer Street | 1745 COPPERHILL PARKWAY |
| Manufacturer City | SANTA ROSA CA 95043 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95043 |
| 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 | 2020-01-10 |
| Returned To Mfg | 2020-01-14 |
| Model Number | CMS15-10C-US |
| Catalog Number | CMS15-10C-US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-10 |