NC EMERGE Adverse Event — Malfunction (MDR 2134265-2020-05659)
NC EMERGE Adverse Event — Malfunction (MDR 2134265-2020-05659) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: NC EMERGE; Generic name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | NC EMERGE |
|---|---|
| Generic name | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05659 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | DEVICE EVALUATED BY MFR.: RETURNED DEVICE CONSISTED OF A NC EMERGE MR BALLOON CATHETER. THE BALLOON WAS LOOSELY FOLDED AND FILLED WITH CONTRAST. THE CONTRAST IN THE DEVICE WAS SOLID, SO THE DEVICE WAS SOAKED IN A WARM WATER BATH FOR 3 DAYS. ANALYSIS OF THE TIP, BALLOON, INNER/OUTER SHAFT AND HYPOTUBE INCLUDED MICROSCOPIC AND VISUAL INSPECTION. INSPECTION FOUND NO DAMAGE OR DEFECT TO THE DEVICE. AF |
| Source | openFDA MAUDE (device adverse events) |
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