GATEWAY PTA DILATATION CATHETER Adverse Event — Malfunction (MDR 2939204-2008-00046)
GATEWAY PTA DILATATION CATHETER Adverse Event — Malfunction (MDR 2939204-2008-00046) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: GATEWAY PTA DILATATION CATHETER; Generic name: (GBA) DILATATION BALLOON CATHETER; Manufacturer: BOSTON SCIENTIFIC.
| Device | GATEWAY PTA DILATATION CATHETER |
|---|---|
| Generic name | (GBA) DILATATION BALLOON CATHETER |
| Manufacturer | BOSTON SCIENTIFIC |
| Report number | 2939204-2008-00046 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-19 |
| Report source | Foreign, Health Professional |
| Narrative | IT WAS REPORTED THAT PHYSICIAN WAS PERFORMING A DILATATION AND STENTING OF INTRACRANIAL STENOSIS. DURING INFLATION WITH CONTRAST MEDIUM AND SALINE FLUID THE PHYSICIAN NOTICED THAT THE BALLOON WAS DAMAGED. THE SYSTEM WAS REMOVED AND THE PHYSICIAN FINISHED THE PROCEDURE WITH ANOTHER SIMILAR CATHETER SUCCESSFULLY. THERE WAS NO ALLEGATION OF HARM. |
| Source | openFDA MAUDE (device adverse events) |
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