MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-05 for SYNERGY ABLATION SYSTEM OLL2 A000362 manufactured by Atricure, Inc..
[134996089]
During ablation, the atricure was placed over the tissue during attempted ablation. The ablation line (burn) on the monitor never dropped below baseline indicating the burn was never completed. Another device was utilized without issue. This patient was not negatively impacted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8304257 |
| MDR Report Key | 8304257 |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-01 |
| Date of Event | 2019-01-29 |
| Report Date | 2019-02-01 |
| Date Reported to FDA | 2019-02-01 |
| Date Reported to Mfgr | 2019-02-05 |
| Date Added to Maude | 2019-02-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNERGY ABLATION SYSTEM |
| Generic Name | SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT OF ATRIAL FIBRILLATION |
| Product Code | OCM |
| Date Received | 2019-02-05 |
| Model Number | OLL2 |
| Catalog Number | A000362 |
| Lot Number | 88837 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRICURE, INC. |
| Manufacturer Address | 7555 INNOVATION WAY MASON OH 45040 US 45040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-05 |