RUBY COIL Adverse Event — Malfunction (MDR 3005168196-2020-00599)
RUBY COIL Adverse Event — Malfunction (MDR 3005168196-2020-00599) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: RUBY COIL; Generic name: HCG, KRD; Manufacturer: PENUMBRA, INC..
| Device | RUBY COIL |
|---|---|
| Generic name | HCG, KRD |
| Manufacturer | PENUMBRA, INC. |
| Report number | 3005168196-2020-00599 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | DISTRIBUTOR, FOREIGN, HEALTH PR |
| Narrative | RESULTS: THE PET LOCK WAS INTACT ON THE PROXIMAL END OF THE PUSHER ASSEMBLY. THE PUSHER ASSEMBLY WAS KINKED AT APPROXIMATELY 1.5 CM FROM ITS PROXIMAL END. THE RUBY COIL WAS LOADED BACKWARD WITHIN ITS INTRODUCER SHEATH. THE EMBOLIZATION COIL WAS INTACT WITH THE PUSHER ASSEMBLY AND HAD OFFSET COIL WINDS AT ITS DISTAL END. CONCLUSIONS: EVALUATION OF THE RETURNED RUBY COIL REVEALED OFFSET COIL WINDS O |
| Source | openFDA MAUDE (device adverse events) |
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