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

Model Number	EMR2
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was not returned for evaluation; however, a comprehensive review of the associated device history record was performed.The review revealed no indications of non-conformance's within the production documentation that could reasonably be associated with the reported complaint.
Event or Problem Description
A patient underwent robotic vats cardiac tissue ablation for treatment of ist using emr2 clamp.A port-a-cath had been placed one day prior for an undisclosed condition.The physician ablated across the svc and did not withdraw the port-a-cath prior to the ablation, despite advisement from atricure personnel in attendance.Post-operatively, a chest x-ray showed that a 2-3 cm segment of port-a-cath had been sheared off and was lodged in lower lobe of patient¿s left lung.The segment was successfully retrieved in a subsequent procedure by interventional radiology.There was no product malfunction, and the event was the result of a use error.

• Brand Name: ISOLATOR® SYNERGY SURGICAL ABLATION SYSTEM
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• 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: 22523718
• Report Number: 3011706110-2025-00029
• Device Sequence Number: 8058540
• Product Code: OCL
• UDI-Device Identifier: 10840143902161
• UDI-Public: (01)10840143902161(17)270301(10)139478
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/16/2025

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: EMR2
• Device Catalogue Number: A000452
• Device Lot Number: 139478
• 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: 06/26/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• 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
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 46 KG