EVERCROSS 035 Adverse Event — Injury (MDR 2183870-2020-00129)
EVERCROSS 035 Adverse Event — Injury (MDR 2183870-2020-00129) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: EVERCROSS 035; Generic name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL; Manufacturer: COVIDIEN.
| Device | EVERCROSS 035 |
|---|---|
| Generic name | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
| Manufacturer | COVIDIEN |
| Report number | 2183870-2020-00129 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | ADDITIONAL INFORMATION: THE EVERCROSS PTA BALLOON WAS USED DURING THE TREATMENT OF A SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). IFU WAS FOLLOWED. THE BALLOON WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE PHYSICIAN USED ADDITIONAL BALLOONS TO COMPLETE THE PROCEDURE. NO VESSEL DAMAGE OCCURRED. NO FURTHER PATIENT INJURY REPORTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH |
| Source | openFDA MAUDE (device adverse events) |
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