STERLING Adverse Event — Malfunction (MDR 2134265-2020-05708)
STERLING Adverse Event — Malfunction (MDR 2134265-2020-05708) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: STERLING; Generic name: CATHETER, PERCUTANEOUS; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | STERLING |
|---|---|
| Generic name | CATHETER, PERCUTANEOUS |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05708 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 5.0X220X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT |
| Source | openFDA MAUDE (device adverse events) |
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