NC EMERGE Adverse Event — Malfunction (MDR 2134265-2020-05758)
NC EMERGE Adverse Event — Malfunction (MDR 2134265-2020-05758) 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 | 2134265-2020-05758 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR ANALYSIS. THE BALLOON WAS LOOSELY FOLDED WITH DRIED BLOOD IN THE DEVICE. ANALYSIS OF THE TIP, BALLOON, INNER/OUTER SHAFT AND HYPOTUBE INCLUDED MICROSCOPIC AND VISUAL INSPECTION. INSPECTION REVEALED NUMEROUS KINKS IN THE HYPOTUBE AND A BURST IN THE BALLOON MATERIAL THAT WAS LOCATED 13MM FROM THE TIP OF THE DEVICE. INSPECTION OF THE REST OF THE D |
| Source | openFDA MAUDE (device adverse events) |
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