FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER Adverse Event — Malfunction (MDR 6000002-2008-05979)
FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER Adverse Event — Malfunction (MDR 6000002-2008-05979) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER; Generic name: EMBOLECTOMY CATHETER; Manufacturer: EDWARDS LIFESCIENCES.
| Device | FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER |
|---|---|
| Generic name | EMBOLECTOMY CATHETER |
| Manufacturer | EDWARDS LIFESCIENCES |
| Report number | 6000002-2008-05979 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-11 |
| Report source | Health Professional, User facility, Company representation |
| Narrative | THE CATHETER SNAPPED INTO LEAVING THE BALLOON INFLATED AND HAD TO BE REMOVED WITH A SNARE. BALLOON DID NOT BREAK BEFORE DEFLATION. NO PT COMPLICATIONS REPORTED. |
| Source | openFDA MAUDE (device adverse events) |
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