HURRICANE RX Adverse Event — Malfunction (MDR 3005099803-2020-01692)
HURRICANE RX Adverse Event — Malfunction (MDR 3005099803-2020-01692) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HURRICANE RX; Generic name: CATHETER, BILIARY, DIAGNOSTIC; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | HURRICANE RX |
|---|---|
| Generic name | CATHETER, BILIARY, DIAGNOSTIC |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 3005099803-2020-01692 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | INVESTIGATION RESULT: A VISUAL EXAMINATION OF THE RETURNED COMPLAINT DEVICE FOUND THAT THE INNER RADIO OPAQUE (RO) MARKERS INSIDE THE BALLOON WERE INSPECTED FOR ANY SHARP EDGE BUT NONE OF THEM SHOWED ABNORMALITIES. FUNCTIONAL EVALUATION WAS PERFORMED AND THE BALLOON WAS INFLATED WITHOUT PROBLEM; HOWEVER, THE BALLOON WOULD NOT HOLD PRESSURE DUE TO A PINHOLE LOCATED NEAR THE PROXIMAL SECTION OF THE |
| Source | openFDA MAUDE (device adverse events) |
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