FLEXTOME CUTTING BALLOON Adverse Event — Malfunction (MDR 2134265-2020-05718)
FLEXTOME CUTTING BALLOON Adverse Event — Malfunction (MDR 2134265-2020-05718) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FLEXTOME CUTTING BALLOON; Generic name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | FLEXTOME CUTTING BALLOON |
|---|---|
| Generic name | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05718 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 10/3.25 FLEXTOME CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED AT 3ATM AND WAS REMOVED PER USUAL. ANOTHER WOLVERINE OF THE SAME SIZE WAS USED, AND THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT PROBLEM REPORTED. |
| Source | openFDA MAUDE (device adverse events) |
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