BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLATOR® SYNERGY SURGICAL ABLATION SYSTEM

    MDR report key: 22628937 · Received July 28, 2025

    Report

    Report Number
    3011706110-2025-00030
    Event Type
    Injury
    Date Received
    July 28, 2025
    Date of Event
    May 25, 2025
    Report Date
    July 28, 2025
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    UDI-DI
    10840143902161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685052 ISOLATOR® SYNERGY SURGICAL ABLATION SYSTEM ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES OCL ATRICURE, INC. EMR2 128075 10840143902161

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female Required Intervention EMR2, ASU, ASB, CATHETER