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	01/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent bilateral video-assisted thoracoscopic approach surgery (vats) with concomitant pulmonary vein isolation using an eml2 clamp.Following the release of the clamp after the third lesion was created, a 2cm hole was discovered in the left atrium where the clamp had been placed.To prevent blood loss, the clamp was reapplied.The patient was then placed on cardiopulmonary bypass, and a small thoracotomy incision was made to repair the hole.The remainder of the procedure was completed successfully.There was no reported device malfunction, and the adverse event was the result of a procedural complication.
Additional Manufacturer Narrative
The device was received for investigation and met all specifications.

• 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 45040 ; 5136448220
• MDR Report Key: 21265622
• Report Number: 3011706110-2025-00009
• Device Sequence Number: 4538580
• Product Code: OCL
• UDI-Device Identifier: 10840143902222
• UDI-Public: (01)10840143902222(17)270601(10)143246C
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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 Model Number: EML2
• Device Catalogue Number: A000467
• Device Lot Number: 143246C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2024
• 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: Required Intervention; Life Threatening
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 62 KG