JETSTREAM XC Adverse Event — Malfunction (MDR 2134265-2020-05640)
JETSTREAM XC Adverse Event — Malfunction (MDR 2134265-2020-05640) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: JETSTREAM XC; Generic name: CATHETER, PERIPHERAL, ATHERECTOMY; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | JETSTREAM XC |
|---|---|
| Generic name | CATHETER, PERIPHERAL, ATHERECTOMY |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05640 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 2.4MM JETSTREAM XC CATHETER WAS SELECTED FOR AN ATHERECTOMY PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). DURING ADVANCEMENT FOR A SECOND PASS USING THIS DEVICE, THE 7FR SHEATH TENTED IN THE AORTA. IT WAS NOTED THAT THE JETSTREAM CATHETER KINKED AND THE DRIVE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER. THERE WERE NO PATIEN |
| Source | openFDA MAUDE (device adverse events) |
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