TREK CORONARY DILATATION CATHETER Adverse Event — Malfunction (MDR 2024168-2020-03981)
TREK CORONARY DILATATION CATHETER Adverse Event — Malfunction (MDR 2024168-2020-03981) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TREK CORONARY DILATATION CATHETER; Generic name: CORONARY DILATATION CATHETER; Manufacturer: ABBOTT VASCULAR.
| Device | TREK CORONARY DILATATION CATHETER |
|---|---|
| Generic name | CORONARY DILATATION CATHETER |
| Manufacturer | ABBOTT VASCULAR |
| Report number | 2024168-2020-03981 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, DISTRI |
| Narrative | THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS AND/OR COMPLAINTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED COMPLAINTS APPEAR TO BE RELATED TO OPERATIONAL |
| Source | openFDA MAUDE (device adverse events) |
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