MUSTANG Adverse Event — Malfunction (MDR 2134265-2020-05776)
MUSTANG Adverse Event — Malfunction (MDR 2134265-2020-05776) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MUSTANG; Generic name: CATHETER, BILIARY, DIAGNOSTIC; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | MUSTANG |
|---|---|
| Generic name | CATHETER, BILIARY, DIAGNOSTIC |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05776 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ANASTOMOSIS ARTERIOVENOUS FISTULA OF THE LEFT UPPER ARM. A 6.0 X 60, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE R |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →