MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-16 for SYNERGY ABLATION SYSTEM OLL2 A000362 manufactured by Atricure, Inc..
[123818530]
The radiofrequency (rf) atricure probe was having issues. Unable to complete the ablation with this probe, and rf machine was showing abnormal waveforms. The unit displayed an error code, and a picture of this was sent to the rep. The patient was on the pump, and heparinized. There was a surgical delay of 5 to 10 minutes. The maze procedure was then able to be completed after opening another oll2 atricure and pulled another rf machine. The asu (ablation sensing unit) had been used once prior to this problem. Manufacturer response for surgical cardiac ablation device, for treatment of atrial fibrillation, synergy ablation system (per site reporter). They requested information regarding the case and have provided a shipper kit to return the device to them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7968645 |
| MDR Report Key | 7968645 |
| Date Received | 2018-10-16 |
| Date of Report | 2018-10-15 |
| Date of Event | 2018-09-14 |
| Report Date | 2018-10-15 |
| Date Reported to FDA | 2018-10-15 |
| Date Reported to Mfgr | 2018-10-16 |
| Date Added to Maude | 2018-10-16 |
| 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 |
| 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 | 2018-10-16 |
| Model Number | OLL2 |
| Catalog Number | A000362 |
| Lot Number | 83943 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRICURE, INC. |
| Manufacturer Address | 6217 CENTRE PARK DRIVE WEST CHESTER OH 45069 US 45069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-16 |