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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The oll2 device was returned for evaluation and visually and functionally tested.The oll2 device, lot number 98510, performed as expected meeting the specification.Unable to confirm complaint.
Event or Problem Description
It was reported that on (b)(6) 2021 a (b)(6) male patient underwent a heparinized, on-pump, arrested mitral valve replacement via trans septal approach.A oll2 clamp was placed and the physician delivered 3 sets of two parallel ablations.During the procedure while ablating the pulmonary veins, a tear was noticed on the atrium.The physician repaired the tear and surgical procedure was prolonged 15 minutes for each side.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: 12977446
• Report Number: 3011706110-2021-00054
• Device Sequence Number: 4316541
• Product Code: OCM
• UDI-Device Identifier: 00818354010503
• UDI-Public: 00818354010503
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 12/10/2021

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 Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 98510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 111 KG