EMERGE Adverse Event — Malfunction (MDR 2134265-2020-05784)
EMERGE Adverse Event — Malfunction (MDR 2134265-2020-05784) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: EMERGE; Generic name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | EMERGE |
|---|---|
| Generic name | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05784 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA IPSILATERAL ANTEGRADE APPROACH. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. AFTER AN UNSPECIFIED GUIDEWIRE CROSSED THE LESION, DILATION WAS PERFORMED WITH 1.2MMX15MMX142CM FG COYOTE FC MR (EMERGE) BALLOON CATHETER. HOWEVER, DURING INFLATION AT UNK |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →