EXTRACTOR RX RETRIEVAL BALLOON Adverse Event — Malfunction (MDR 3005099803-2008-00195)
EXTRACTOR RX RETRIEVAL BALLOON Adverse Event — Malfunction (MDR 3005099803-2008-00195) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: EXTRACTOR RX RETRIEVAL BALLOON; Manufacturer: BOSTON SCIENTIFIC CORK, LTD.; Report number: 3005099803-2008-00195.
| Device | EXTRACTOR RX RETRIEVAL BALLOON |
|---|---|
| Manufacturer | BOSTON SCIENTIFIC CORK, LTD. |
| Report number | 3005099803-2008-00195 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-22 |
| Report source | Other, Foreign, Health Professional, Company representation |
| Narrative | AN EXTRACTOR RX RETRIEVAL BALLOON WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (PT AGE, GENDER AND WEIGHT UNK) IN 2008. ACCORDING TO THE COMPLAINANT, THE BALLOON WAS "USED TO TRAWL STONE. [THE] BALLOON THEN BURST, [AND] WHEN REMOVING [THE DEVICE] FROM THE COMMON BILE DUCT, PART OF THE BALLOON [WAS] TRAPPED IN THE COMMON BILE DUCT." AN ATTEMPT TO REMOVE THE BALLOON FRAGME |
| Source | openFDA MAUDE (device adverse events) |
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