POWERFLEXPRO 5MM22CM 135 Adverse Event — Malfunction (MDR 9616099-2020-03676)
POWERFLEXPRO 5MM22CM 135 Adverse Event — Malfunction (MDR 9616099-2020-03676) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: POWERFLEXPRO 5MM22CM 135; Generic name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL; Manufacturer: CORDIS CORPORATION.
| Device | POWERFLEXPRO 5MM22CM 135 |
|---|---|
| Generic name | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
| Manufacturer | CORDIS CORPORATION |
| Report number | 9616099-2020-03676 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | COMPLAINT CONCLUSION: DURING PROCEDURE, THE 5MM X 22CM 135CM POWERFLEX PRO WAS RUPTURED AT THE CALCIFIED VESSEL. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS RETURNED FOR ANALYSIS. A NON-STERILE POWERFLEX PRO 5MM X 22CM 135 WAS RECEIVED FOR ANALYSIS COILED INSIDE A PLASTIC BAG. PER VISUAL ANALYSIS, THE BALLOON APPEARS TO HAVE BEEN PREVIOUSLY INFLATED. BLOOD RESIDUES WERE OBSERVED INSIDE T |
| Source | openFDA MAUDE (device adverse events) |
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