INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER Adverse Event — Malfunction (MDR 2134265-2020-05631)
INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER Adverse Event — Malfunction (MDR 2134265-2020-05631) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; Generic name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF A; Man
| Device | INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER |
|---|---|
| Generic name | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF A |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2020-05631 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. |
| Source | openFDA MAUDE (device adverse events) |
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