DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM Adverse Event — Injury (MDR 3004742232-2020-00131)
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM Adverse Event — Injury (MDR 3004742232-2020-00131) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; Generic name: PERIPHERAL ATHERECTOMY DEVICE; Manufacturer: CARDIOVASCUL
| Device | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM |
|---|---|
| Generic name | PERIPHERAL ATHERECTOMY DEVICE |
| Manufacturer | CARDIOVASCULAR SYSTEMS, INC. |
| Report number | 3004742232-2020-00131 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THE REPORTED OAD AND THE VIPERWIRE GUIDE WIRE USED IN THE PROCEDURE WERE RECEIVED AT CSI FOR ANALYSIS. THE GUIDE WIRE WAS ENGAGED IN THE OAD, AND WAS REMOVED WITH SOME RESISTANCE. WHEN RE-INSERTED, THE WIRE WOULD NOT PASS AN AREA OF SIGNIFICANT ADHERED BIOLOGICAL MATERIAL OBSERVED ON THE DRIVESHAFT AND CROWN. ALTHOUGH THE ROOT CAUSE OF THE ACCUMULATING TISSUE IS UNKNOWN, IT IS HYPOTHESIZED THAT TH |
| Source | openFDA MAUDE (device adverse events) |
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