MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-11-09 for ATRICURE SYNERGY ABLATION SYSTEM OLL2 A00362 manufactured by Atricure Inc..
[59554224]
(b)(4). The device has not yet been returned to atricure for evaluation. If additional information is received a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[59554225]
It was reported that during a concomitant aortic valve replacement procedure, transmurality on the unit was not recognized when tissue had been ablated. The surgeon stated after performing many ablations it kept going to 30 seconds. By doing so many ablations and the machine not recognizing when transmurality was complete, a hole in the atrium was formed and bleeding had begun once by-pass was reversed. The tear was closed with a bovine pericardial patch and the procedure completed. The patient made an uneventful recovery thereafter with no long term adverse consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003502395-2016-00158 |
| MDR Report Key | 6091418 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-09 |
| Date of Report | 2016-10-14 |
| Date of Event | 2016-08-09 |
| Date Mfgr Received | 2016-10-14 |
| Date Added to Maude | 2016-11-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS. RANJANA IYER |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer Phone | 5137555328 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATRICURE SYNERGY ABLATION SYSTEM |
| Generic Name | ISOLATOR SYNERGY CLAMP LONG JAW |
| Product Code | OCM |
| Date Received | 2016-11-09 |
| Model Number | OLL2 |
| Catalog Number | A00362 |
| Lot Number | 60789 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Life Threatening; 2. Required No Informationntervention | 2016-11-09 |