MAUDE Adverse Event Report: ATRICURE, INC. ATRICURE SYNERGY ABLATION SYSTEM

Model Number	OLL2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) the device was not returned for investigation.However, the device history record was reviewed and there is nothing in the product history record that would indicate that the devices were released with any non-conformances that would contribute to the subject complaint.
Event or Problem Description
On (b)(6) 2022, a patient underwent an on-pump ascending aorta graft with pulmonary vein isolation and left atrial appendage exclusion.When the surgeon was attempting to go around the left pulmonary veins to perform a pulmonary vein isolation using the oll2 clamp, an unintended perforation was made.Surgeon sutured the perforation, and no complications were observed.The pulmonary vein isolation was then aborted.It was noted that the patient had a large aortic aneurysm which made visibility and access difficult.Post-op the patient was doing well.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: ATRICURE SYNERGY ABLATION SYSTEM
• Common Device Name: ATRICURE SYNERGY ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 14950448
• Report Number: 3011706110-2022-00022
• Device Sequence Number: 12136851
• Product Code: OCM
• UDI-Device Identifier: 00818354010503
• UDI-Public: 00818354010503
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P100046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2024
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 116209
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown