VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER Adverse Event — Injury (MDR 3004742046-2008-00035)
VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER Adverse Event — Injury (MDR 3004742046-2008-00035) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER; Manufacturer: ABBOTT VASCULAR-VASCULAR SOLUTIONS; Report number: 3004742046-2008-0003
| Device | VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER |
|---|---|
| Manufacturer | ABBOTT VASCULAR-VASCULAR SOLUTIONS |
| Report number | 3004742046-2008-00035 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Foreign, Health Professional, Company representation |
| Narrative | DEVICE MALFUNCTION: SHAFT BREAKAGE, RUPTURED AND DETACHED BALLOON. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT THE VIATRAC WAS USED DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY. THE BALLOON REPORTEDLY RUPTURED CIRCUMFERENTIALLY AT AN UNSPECIFIED PRESSURE. DURING WITHDRAWAL OF THE VIATRAC FROM THE PT, A PORTION OF |
| Source | openFDA MAUDE (device adverse events) |
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