HURRICANE RX Adverse Event — Malfunction (MDR 3005099803-2020-01731)
HURRICANE RX Adverse Event — Malfunction (MDR 3005099803-2020-01731) 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 | 3005099803-2020-01731 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN; HOWEVER, IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (B)(4): INVESTIGATION RESULT: A VISUAL EXAMINATION OF THE RETURNED COMPLAINT DEVICE FOUND THAT THE DEVICE DID NOT HAVE ANY DAMAGES. THE INNER RADIO OPAQUE (RO) MARKERS INSIDE THE BALLOON WERE INSPECTED FOR ANY SHAR |
| Source | openFDA MAUDE (device adverse events) |
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