MAXFORCE Adverse Event — Malfunction (MDR 3005099803-2020-01670)
MAXFORCE Adverse Event — Malfunction (MDR 3005099803-2020-01670) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MAXFORCE; Generic name: CATHETER, BILIARY, DIAGNOSTIC; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | MAXFORCE |
|---|---|
| Generic name | CATHETER, BILIARY, DIAGNOSTIC |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 3005099803-2020-01670 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). INVESTIGATION RESULTS: A VISUAL EXAMINATION OF THE RETURNED COMPLAINT DEVICE FOUND THAT THE BALLOON DID NOT HAVE ANY VISUAL DEFECTS AND WAS IN A GOOD CONDITION. THE CATHETER OF THE DEVICE WAS CAREFULLY INSPECTED AND NO DAMAGES WERE FOUND. FUNCTIONAL ANALYSIS WAS ATTEMPTED TO BE PERFORMED; HOWEVER, THE BALLOON LUMEN WAS OCCLUDED AND COULD NOT BE UNBLOCKED. A MICROSCOPIC EXAMINATION OF THE B |
| Source | openFDA MAUDE (device adverse events) |
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