MYNXGRIP VASCULAR CLOSURE DEVICE 5F Adverse Event — Malfunction (MDR 3004939290-2020-01741)
MYNXGRIP VASCULAR CLOSURE DEVICE 5F Adverse Event — Malfunction (MDR 3004939290-2020-01741) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MYNXGRIP VASCULAR CLOSURE DEVICE 5F; Generic name: DEVICE, HEMOSTASIS, VASCULAR; Manufacturer: CORDIS SANTA CLARA.
| Device | MYNXGRIP VASCULAR CLOSURE DEVICE 5F |
|---|---|
| Generic name | DEVICE, HEMOSTASIS, VASCULAR |
| Manufacturer | CORDIS SANTA CLARA |
| Report number | 3004939290-2020-01741 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | COMPLAINT CONCLUSION:DURING THE USE OF A 5F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD), THE ADVANCER TUBE SEEMED TO BE KINKED WHICH CAUSED THE DEVICE TO NOT DEPLOY PROPERLY AND THE ADVANCER TUBE NOT TO SHUTTLE DOWN PROPERLY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN STERILE FIELD AND WAS STORED AS PER LABELING. THE TYPE OF PROCEDURE THAT THE MYNX VCD WAS USED IN WAS INTERVENTIONAL |
| Source | openFDA MAUDE (device adverse events) |
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