MAVERICK Adverse Event — Malfunction (MDR 2134265-2020-05646)
MAVERICK Adverse Event — Malfunction (MDR 2134265-2020-05646) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MAVERICK; Generic name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | MAVERICK |
|---|---|
| Generic name | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05646 |
| 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 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY. A 2.00MM X 20MM MAVERICK 2 BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 6 ATMOSPHERES FOR 7 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH |
| Source | openFDA MAUDE (device adverse events) |
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