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 2017-10-07 for ATRICURE SYNERGY ABLATION SYSTEM OSL2 A000432 manufactured by Atricure, Inc..
[88944902]
(b)(4). The device was returned for evaluation and visually and functionally tested. Upon evaluation, device met all criteria and functioned normally. The complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[88944903]
On (b)(6) 2017, a female patient received an on pump, concomitant mvr/maze procedure with laa management, using an atricure synergy ablation system. During the procedure, the surgeon created lesions using an isolator synergy clamp, standard jaw (osl2) for pvi and then a max1 isolator transpolar pen for epicardial roof and floor lesions with no pv dissection. The pvi lesions were created with two applications of the clamp, including a set of vertical lesions. The laa was removed and sewn shut; the surgeon did not indicate whether this was before or after the ablation. When the patient had been taken off-pump and the surgeon was ready to close the chest, bleeding was noted between the ablation lines near the laa and left pv. The patient was placed back on pump and a suture was applied to stop the bleeding which prolonged the procedure. The mvr, the maze and the laa removal were completed prior to the complication. The patient was doing well as of (b)(6) 2017. No device malfunction or other complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2017-00088 |
| MDR Report Key | 6926186 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-07 |
| Date of Report | 2017-10-06 |
| Date of Event | 2017-09-11 |
| Date Mfgr Received | 2017-09-12 |
| Device Manufacturer Date | 2017-07-10 |
| Date Added to Maude | 2017-10-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANUPAM BEDI |
| Manufacturer G1 | ATRICURE, INC. |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATRICURE SYNERGY ABLATION SYSTEM |
| Generic Name | ATRICURE SYNERGY ABLATION SYSTEM |
| Product Code | OCM |
| Date Received | 2017-10-07 |
| Returned To Mfg | 2017-10-03 |
| Model Number | OSL2 |
| Catalog Number | A000432 |
| Lot Number | 75112 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2017-10-07 |