MAXFORCE Adverse Event — Malfunction (MDR 3005099803-2020-01662)
MAXFORCE Adverse Event — Malfunction (MDR 3005099803-2020-01662) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MAXFORCE; Generic name: CATHETER, BILIARY, DIAGNOSTIC; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | MAXFORCE |
|---|---|
| Generic name | CATHETER, BILIARY, DIAGNOSTIC |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 3005099803-2020-01662 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | BLOCK E1: INITIAL REPORTER PHONE: (B)(6). BLOCK H6: PROBLEM CODE 1074 CAPTURES THE REPORTABLE ISSUE OF BALLOON BURST. BLOCK H10: INVESTIGATION RESULTS A VISUAL EXAMINATION OF THE RETURNED COMPLAINT DEVICE FOUND THAT THE BALLOON DID NOT SHOW ANY VISUAL DEFECTS AND WAS IN A GOOD CONDITION. NO DAMAGE FOUND ON THE CATHETER OF THE DEVICE. FUNCTIONAL EVALUATION WAS PERFORMED AND THE BALLOON WAS INFLATED |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →