COYOTE ES Adverse Event — Malfunction (MDR 2134265-2020-05689)
COYOTE ES Adverse Event — Malfunction (MDR 2134265-2020-05689) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: COYOTE ES; Generic name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | COYOTE ES |
|---|---|
| Generic name | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05689 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED BELOW KNEE VESSEL. A 3MM X 40MM X 146CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICA |
| Source | openFDA MAUDE (device adverse events) |
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