ROTALINK PLUS Adverse Event — Malfunction (MDR 2134265-2020-05667)
ROTALINK PLUS Adverse Event — Malfunction (MDR 2134265-2020-05667) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ROTALINK PLUS; Generic name: CATHETER, CORONARY, ATHERECTOMY; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | ROTALINK PLUS |
|---|---|
| Generic name | CATHETER, CORONARY, ATHERECTOMY |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05667 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | IT WAS REPORTED THAT THE BURR BECAME NOT STERILE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 1.25MM ROTALINK PLUS WAS SELECTED FOR USE. DURING PREPARATION, WHILE TESTING THE DEVICE, IT WAS NOTED THAT THE BURR BECAME ENTANGLED IN THE CLOTH AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATI |
| Source | openFDA MAUDE (device adverse events) |
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