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

Model Number	OLL2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/17/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Case- (b)(4) the oll2 device was not returned for evaluation, but a device history review was obtained for lot number 111400.There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.
Event or Problem Description
It was reported that on (b)(6) 2021, an (b)(6)-year-old male patient underwent an on-pump, heparinized intra-aortic balloon pump insertion, mammary take down, triple coronary artery bypass graft, bi-atrial maze, a left atrial appendage ligation, and aortic valve replacement.Upon completion of these procedures while coming off cardiopulmonary bypass, bleeding was noted.The patient was placed back on cardiopulmonary bypass, and the heart was re-arrested to repair the left atrial roof line.Patient was stable post-procedure.There was no reported device malfunction, and the adverse event was the result of a procedural complication.
Additional Manufacturer Narrative
Case-(b)(4) updated fields b2 and h1 as it was later learned that the patient expired.There is no cause of death and no autopsy results.

• Brand Name: SYNERGY¿ ABLATION SYSTEM
• Common Device Name: 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: 12605208
• Report Number: 3011706110-2021-00043
• Device Sequence Number: 13806724
• Product Code: OCM
• UDI-Device Identifier: 00818354010503
• UDI-Public: 00818354010503
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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: 06/01/2024
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 111400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CRYO2, PROV50, ASU/ASB.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Death
• Patient Age: 83 YR
• Patient Sex: Male