FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM Adverse Event — Malfunction (MDR 2024168-2008-00103)
FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM Adverse Event — Malfunction (MDR 2024168-2008-00103) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM; Generic name: 74MCX; Manufacturer: ABBOTT VASCULAR-CARDIAC THERAPIES.
| Device | FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM |
|---|---|
| Generic name | 74MCX |
| Manufacturer | ABBOTT VASCULAR-CARDIAC THERAPIES |
| Report number | 2024168-2008-00103 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-14 |
| Report source | Foreign, Health Professional, Company representation |
| Narrative | RESULTS AND CONCLUSIONS SUMMATION: BALLOON RUPTURES MAY OCCUR DUE TO, BUT NOT LIMITED TO, MFG ISSUES, MATERIALS, MECHANICAL DAMAGE, HANDLING OF THE DEVICE DURING USE, OVER INFLATION AND/OR INTERACTION WITH PT ANATOMY OR INTERACTION WITH ASSOCIATED DEVICES. IT WAS REPORTED THAT THE LESION WAS CALCIFIED, 75% STENOSED, WHICH MAY HAVE CONTRIBUTED TO THE FAILURE. SINCE THE DEVICES WERE ABLE TO BE PREPP |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →