FDA Adverse Event
Malfunction
Summary report: N
SENTINEL CEREBRAL PROTECTION SYSTEM (US)
MDR report key: 10548940
·
Received September 17, 2020
Report
- Report Number
- 2134265-2020-12465
- Event Type
- Malfunction
- Date Received
- September 17, 2020
- Date of Event
- August 19, 2020
- Report Date
- September 17, 2020
- Manufacturer
- CLARET MEDICAL, INC.
- Product Code
- PUM
- UDI-DI
- 00863229000004
- PMA / PMN Number
- DEN160043
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT FAILURE TO REMOVE THROUGH THE INTRODUCER SHEATH OCCURRED. A SENTINEL CEREBRAL PROTECTION SYSTEM WAS SELECTED FOR THE PROCEDURE. WHEN THE SENTINEL CEREBRAL PROTECTION SYSTEM WAS BEING REMOVED, RESISTANCE WAS FELT. THE SENTINEL CEREBRAL PROTECTION SYSTEM WAS NOT ABLE TO BE REMOVED THROUGH THE 5-6 NON-BSC SHEATH. THERE WERE NO PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1009285 | SENTINEL CEREBRAL PROTECTION SYSTEM (US) | EMBOLIC PROTECTION DEVICE | PUM | CLARET MEDICAL, INC. | CMS15-10C-US | 0025667800 | 00863229000004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |