MAVERICK Adverse Event — Malfunction (MDR 2134265-2020-05677)
MAVERICK Adverse Event — Malfunction (MDR 2134265-2020-05677) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MAVERICK; Generic name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | MAVERICK |
|---|---|
| Generic name | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05677 |
| 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 GUIDEZILLA 2 GUIDE EXTENSION CATHETER. THERE WAS BLOOD IN THE BALLOON AND LUMEN. ANALYSIS OF THE TIP, INNER/OUTER SHAFT AND HYPOTUBE INCLUDED MICROSCOPIC AND VISUAL INSPECTION. INSPECTION REVEALED A BURST IN THE BALLOON THAT WAS 10MM IN LENGTH, AND NUMEROUS KINKS IN THE HYPOTUBE. INSPECTION OF THE REST OF THE DEVICE FOUND NO OTHER DAMAGE OR |
| Source | openFDA MAUDE (device adverse events) |
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