ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER Adverse Event — Malfunction (MDR 3002648230-2020-00243)
ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER Adverse Event — Malfunction (MDR 3002648230-2020-00243) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER; Generic name: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF
| Device | ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER |
|---|---|
| Generic name | PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRI |
| Manufacturer | MEDTRONIC CRYOCATH LP |
| Report number | 3002648230-2020-00243 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | PATIENT FILES SHOWED AT LEAST FOUR APPLICATIONS WITH CATHETER AFAPRO28 LOT # 98500 AND FIVE APPLICATIONS WERE PERFORMED WITH A SECOND CATHETER AFAPRO28 LOT # 98500 WITHOUT ANY ISSUE ON THE DATE OF THE EVENT. VISUAL INSPECTION OF BALLOON CATHETER SHOWED THERE IS TRACES OF BLOOD INSIDE THE BALLOONS. SMART CHIP VERIFICATION SHOWED FOUR APPLICATIONS WERE PERFORMED WITH THE CATHETER. THE CATHETER FAILE |
| Source | openFDA MAUDE (device adverse events) |
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