SENTINEL Adverse Event — Malfunction (MDR 10000579)
SENTINEL Adverse Event — Malfunction (MDR 10000579) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SENTINEL; Generic name: TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRAC; Manufacturer: CLARET MEDICAL, INC..
| Device | SENTINEL |
|---|---|
| Generic name | TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRAC |
| Manufacturer | CLARET MEDICAL, INC. |
| Report number | 10000579 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Narrative | SENTINEL DEVICE WAS INSERTED VIA THE RIGHT RADIAL ARTERY OVER A CHOICE EXTRA STIFF WIRE. ONCE THE DEVICE WAS IN THE PATIENT'S BODY THE DOCTOR TRIED TO ADJUST USING THE KNOB LABELED 2, BUT THE KNOB JUST TURNED AND TURNED AND TURNED AND DID NOT DO ANYTHING FUNCTIONAL. THEY TRIED TO ADJUST THE KNOB BUT IT JUST WOULDN'T DO WHAT IT WAS SUPPOSED TO DO. A NEW DEVICE WAS USED AND WORKED FINE (SAME LOT NUM |
| Source | openFDA MAUDE (device adverse events) |
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