POD PACKING COIL Adverse Event — Malfunction (MDR 3005168196-2020-00598)
POD PACKING COIL Adverse Event — Malfunction (MDR 3005168196-2020-00598) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: POD PACKING COIL; Generic name: HCG, KRD; Manufacturer: PENUMBRA, INC..
| Device | POD PACKING COIL |
|---|---|
| Generic name | HCG, KRD |
| Manufacturer | PENUMBRA, INC. |
| Report number | 3005168196-2020-00598 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | DISTRIBUTOR, FOREIGN, HEALTH PR |
| Narrative | RESULTS: THE PUSHER ASSEMBLY WAS FRACTURED APPROXIMATELY 5.0 CM FROM THE PROXIMAL END. THE PULL WIRE WAS RETRACTED OUT OF THE DISTAL DETACHMENT TIP (DDT) AND THE EMBOLIZATION COIL WAS DETACHED FROM ITS PUSHER ASSEMBLY. CONCLUSIONS: EVALUATION OF THE RETURNED POD PC CONFIRMED THAT THE EMBOLIZATION COIL WAS DETACHED FROM ITS PUSHER ASSEMBLY. FURTHER EVALUATION REVEALED THAT THE PUSHER ASSEMBLY WAS F |
| Source | openFDA MAUDE (device adverse events) |
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