ROTAPRO Adverse Event — Malfunction (MDR 2134265-2020-05586)
ROTAPRO Adverse Event — Malfunction (MDR 2134265-2020-05586) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ROTAPRO; Generic name: CATHETER, CORONARY, ATHERECTOMY; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | ROTAPRO |
|---|---|
| Generic name | CATHETER, CORONARY, ATHERECTOMY |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05586 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE GUIDEWIRE. A 1.5MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR A PROCEDURE. DURING THE PROCEDURE ON THE EIGHTH RUN, THE SYSTEM WAS STALLED AND THERE WAS A DEGREE OF DECELERATION TO MAXIMUM 7000 RPM. AFTER THAT, DEVICE WAS RETRIEVED, BUT THE BURR BECAME STUCK ON THE GUIDEWIRE. SINCE ONLY THE CATHETER COULD NOT BE RETRIEVED, THE CATHETER AND THE WIRE WERE |
| Source | openFDA MAUDE (device adverse events) |
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