MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR® SYNERGY SURGICAL ABLATION SYSTEM; ELECTROSURGICAL DEVICE

Model Number	EML2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a totally thoracoscopic maze procedure.During insertion of the eml2 clamp around the left pulmonary veins (lpv), the lpv was torn, and bleeding occurred.A midline incision was performed, and the injury was repaired.The patient is recovering.There was no reported device malfunction, and the adverse event was the result of a procedural complication.
Additional Manufacturer Narrative
The device was not returned for evaluation however, a device history review was conducted 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.

• Brand Name: ISOLATOR® SYNERGY SURGICAL ABLATION SYSTEM
• Common Device Name: ELECTROSURGICAL DEVICE
• 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 45140 ; 5136448220
• MDR Report Key: 21061511
• Report Number: 3011706110-2025-00001
• Device Sequence Number: 15440686
• Product Code: OCL
• UDI-Device Identifier: 10840143902222
• UDI-Public: (01)10840143902222(17)270401(10)140248
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K221358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2025

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: 02/01/2026
• Device Model Number: EML2
• Device Catalogue Number: A000467
• Device Lot Number: 140248
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2024
• 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: Life Threatening; Required Intervention
• Patient Sex: Female