MAUDE Adverse Event Report: ATRICURE, INC. SYNERGY ABLATION SYSTEM; SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	OLL2
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: SYNERGY ABLATION SYSTEM
• Common Device Name: SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 8304257
• Report Number: 8304257
• Device Sequence Number: 16469820
• Product Code: OCM
• UDI-Device Identifier: 00818354010503
• UDI-Public: (01)00818354010503(17)211101(10)88837
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2019
• Report Date (Section F): 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 88837
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/01/2019