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	05/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent cardiac tissue ablation for treatment of ist using emr2 clamp as part of the heal-ist ide trial (g210309).A picc line had been previously placed for an undisclosed condition.The physician ablated across the svc and did not withdraw the picc line prior to the ablation, despite advisement from atricure personnel in attendance.A chest x-ray done on (b)(6) 2025 showed a potential foreign body in patient's left pulmonary artery.It was determined that the foreign body was the tip of a picc line which was damaged during the epicardial ablation.The patient was admitted on (b)(6) 2025 for removal of the ¿distal fragment of the picc line¿ by interventional radiology.There was no product malfunction, and the event was the result of a use error.
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-conformances within the production documentation that could reasonably be associated with the reported complaint.

• 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 45140 ; 5136448220
• MDR Report Key: 22628937
• Report Number: 3011706110-2025-00030
• Device Sequence Number: 12756997
• Product Code: OCL
• UDI-Device Identifier: 10840143902161
• UDI-Public: (01)10840143902161(17)260301(10)128075
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2025

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: 03/01/2026
• Device Model Number: EMR2
• Device Catalogue Number: A000452
• Device Lot Number: 128075
• 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: 07/11/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EMR2, ASU, ASB, CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Sex: Female