QUANTUM MAVERICK MONORAIL BALLOON CATHETER Adverse Event — Malfunction (MDR 2134265-2008-00456)
QUANTUM MAVERICK MONORAIL BALLOON CATHETER Adverse Event — Malfunction (MDR 2134265-2008-00456) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: QUANTUM MAVERICK MONORAIL BALLOON CATHETER; Generic name: LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEO; Manufacturer: B
| Device | QUANTUM MAVERICK MONORAIL BALLOON CATHETER |
|---|---|
| Generic name | LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEO |
| Manufacturer | BOSTON SCIENTIFIC |
| Report number | 2134265-2008-00456 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Foreign, Health Professional, Company representation |
| Narrative | RETURNED DEVICE ANALYSIS WAS UNABLE TO VERIFY THE EVENT DESCRIPTION. HOWEVER, ANALYSIS DID REVEAL A BALLOON TEAR. THE BALLOON CATHETER WAS RECEIVED IN GOOD CONDITION, WITH NO DAMAGE OBSERVED, AND WITH THE BALLOON IN A DEFLATED STATE. VISUAL AND MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL THAT WAS 3 MILLIMETERS IN LENGTH AND LOCATED 11 MILLIMETER |
| Source | openFDA MAUDE (device adverse events) |
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