FOX PLUS PTA CATHETER Adverse Event — Malfunction (MDR 9710478-2008-00016)
FOX PLUS PTA CATHETER Adverse Event — Malfunction (MDR 9710478-2008-00016) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FOX PLUS PTA CATHETER; Manufacturer: ABBOTT VASCULAR SWITZERLAND; Report number: 9710478-2008-00016.
| Device | FOX PLUS PTA CATHETER |
|---|---|
| Manufacturer | ABBOTT VASCULAR SWITZERLAND |
| Report number | 9710478-2008-00016 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-18 |
| Report source | Foreign, Health Professional, Company representation |
| Narrative | DEVICE MALFUNCTION: BALLOON RUPTURE. TIME OF DEVICE MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING PRE-DILATATION OF A MILDLY TORTUOUS, MODERATELY CALCIFIED, ECCENTRIC, 99% STENOSED SUPERFICIAL FEMORAL ARTERY (SFA) THE FOX PLUS BALLOON CATHETER RUPTURED AT 8 ATM. THE PROCEDURE WAS COMPLETED USING A FOX PLUS SV BALLOON CATHETER. THERE WERE NO REPORTED ADVERSE PT E |
| Source | openFDA MAUDE (device adverse events) |
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