ANGIOJET SOLENT DISTA Adverse Event — Malfunction (MDR 2134265-2020-05672)
ANGIOJET SOLENT DISTA Adverse Event — Malfunction (MDR 2134265-2020-05672) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ANGIOJET SOLENT DISTA; Generic name: CATHETER, EMBOLECTOMY; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | ANGIOJET SOLENT DISTA |
|---|---|
| Generic name | CATHETER, EMBOLECTOMY |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05672 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | DEVICE EVALUATED BY THE MANUFACTURER: RETURNED PRODUCT CONSISTED OF A SOLENT DISTA THROMBECTOMY SYSTEM. THE PUMP, EFFLUENT/SUPPLY LINE, SHAFT, TIP, PISTON, AND SPIKE LINE WERE MICROSCOPICALLY AND VISUALLY INSPECTED. INSPECTION OF THE DEVICE REVEALED THAT THE SHAFT WAS KINKED 6.5CM PROXIMAL OF THE TIP. THE HYPOTUBE AT THIS LOCATION WAS BROKEN. THE SEPARATED ENDS OF THE HYPOTUBE WERE OVALED, INDICAT |
| Source | openFDA MAUDE (device adverse events) |
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