ACS RX ESPRIT CORONARY DILATATION CATHETERS (PERFUSION) Adverse Event — Malfunction (MDR 2024168-2008-00112)
ACS RX ESPRIT CORONARY DILATATION CATHETERS (PERFUSION) Adverse Event — Malfunction (MDR 2024168-2008-00112) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ACS RX ESPRIT CORONARY DILATATION CATHETERS (PERFUSION); Generic name: 74LOX; Manufacturer: ABBOTT VASCULAR-CARDIAC THERAP
| Device | ACS RX ESPRIT CORONARY DILATATION CATHETERS (PERFUSION) |
|---|---|
| Generic name | 74LOX |
| Manufacturer | ABBOTT VASCULAR-CARDIAC THERAPIES |
| Report number | 2024168-2008-00112 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-14 |
| Report source | Foreign, Health Professional, Company representation |
| Narrative | REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO A PATIENT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE LESION WAS LOCATED IN THE PROXIMAL RCA AND HAD MILD TORTUOSITY, MILD CALCIFICATION, AND 100% STENOSIS. TWO GUIDE WIRES WERE USED TO CROSS THE LESION AND PRE-DILATATION WAS PERFORMED USING ANOTHER COMPANY'S BALLOON CATHETER |
| Source | openFDA MAUDE (device adverse events) |
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