MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F Adverse Event — Malfunction (MDR 3004939290-2020-01740)
MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F Adverse Event — Malfunction (MDR 3004939290-2020-01740) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F; Generic name: DEVICE, HEMOSTASIS, VASCULAR; Manufacturer: CORDIS SANTA CLARA.
| Device | MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F |
|---|---|
| Generic name | DEVICE, HEMOSTASIS, VASCULAR |
| Manufacturer | CORDIS SANTA CLARA |
| Report number | 3004939290-2020-01740 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | AS REPORTED, THE BALLOONS OF THE 4 5F MYNXGRIP VASCULAR CLOSURE DEVICES (VCD) POPPED. THE PHYSICIAN INFLATED THE FIRST BALLOON INSIDE THE PATIENT AND THE BALLOON RUPTURED. THE PHYSICIAN INFLATED ¿TWO OR THREE MORE¿ ON THE TABLE AND ALL OF THEM RUPTURED. THERE WAS NO HARM TO THE PATIENT AND A MANUAL HOLD/PRESSURE WAS PERFORMED TO ACHIEVE HEMOSTASIS. THE PHYSICIAN IS A CERTIFIED USER. OTHER ADDITION |
| Source | openFDA MAUDE (device adverse events) |
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