2CM PERIPHERAL CUTTING BALLOON Adverse Event — Malfunction (MDR 2134265-2020-05691)
2CM PERIPHERAL CUTTING BALLOON Adverse Event — Malfunction (MDR 2134265-2020-05691) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: 2CM PERIPHERAL CUTTING BALLOON; Generic name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | 2CM PERIPHERAL CUTTING BALLOON |
|---|---|
| Generic name | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05691 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | IT WAS REPORTED THAT A BALLOON BURST OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT CEPHALIC VEIN. A 5.00MMM/2.0CM/90CM PERIPHERAL CUTTING BALLOON WAS SELECTED FOR USE IN AN AVF PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE PROCEDURE, AT FIRST INFLATION, THE BALLOON BURSTED AT 8ATM FOR 3 SECONDS. HOWEVER, IT WAS FURTHER REPORTED THAT A |
| Source | openFDA MAUDE (device adverse events) |
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