VOYAGER RX CORONARY DILATATION CATHETER Adverse Event — Malfunction (MDR 2024168-2008-00118)
VOYAGER RX CORONARY DILATATION CATHETER Adverse Event — Malfunction (MDR 2024168-2008-00118) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VOYAGER RX CORONARY DILATATION CATHETER; Generic name: 74LOX; Manufacturer: ABBOTT VASCULAR-CARDIAC THERAPIES.
| Device | VOYAGER RX CORONARY DILATATION CATHETER |
|---|---|
| Generic name | 74LOX |
| Manufacturer | ABBOTT VASCULAR-CARDIAC THERAPIES |
| Report number | 2024168-2008-00118 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-19 |
| Report source | Health Professional, Company representation |
| Narrative | REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN A VERY CALCIFIED ARTERY. BOTH OF THE VOYAGER BALLOONS RUPTURED AT LOW PRESSURE. THERE WERE NO PT EFFECTS REPORTED. NO ADD'L EVENT OR PT INFO IS AVAILABLE. |
| Source | openFDA MAUDE (device adverse events) |
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