BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLATOR SYNERGY

    MDR report key: 2993856 · Received March 4, 2013

    Report

    Report Number
    3003502395-2013-00002
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 4, 2013
    Manufacturer
    ATRICURE, INC.
    Product Code
    GEI
    PMA / PMN Number
    P100046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO ATRICURE FOR EVALUATION. THE USER INDICATED THAT THE EVENT WAS DUE TO PROCEDURAL ERROR AND NO DEFECT OF THE DEVICE WAS INDICATED. THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    DURING A PULMONARY VEIN ISOLATION PROCEDURE, THE DOCTOR ATTEMPTED ABLATION ABOUT SIX TIMES WITH THE CLAMP. AFTER THAT, A FULL MAZE AND MITRAL VALVULOPLASTY WERE CONDUCTED IN A STATE OF CARDIOPULMONARY ARREST. AFTER THE PROCEDURE WHEN CARDIAC BEAT WAS RESTARTED, THE DOCTOR FOUND OOZING OF BLOOD FROM THE ABLATION LINE WHICH WAS SUTURED BY 5-0 PROLINE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE DOCTOR INDICATED THE ISSUE WAS NOT DUE TO ANY ISSUES WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91475 ISOLATOR SYNERGY ELECTROSURGICAL CUTTING/COAGULATION DEVI GEI ATRICURE, INC. OLL2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention