FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER Adverse Event — Injury (MDR 3005334138-2020-00168)
FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER Adverse Event — Injury (MDR 3005334138-2020-00168) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER; Generic name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREAT
| Device | FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER |
|---|---|
| Generic name | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF A |
| Manufacturer | ST. JUDE MEDICAL |
| Report number | 3005334138-2020-00168 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | FOREIGN, LITERATURE |
| Narrative | THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS NOT REVIEWED AS THE BATCH NUMBER WAS NOT AVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION COULD NOT BE CONCLUSIVELY DETERMINED. |
| Source | openFDA MAUDE (device adverse events) |
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