BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLATOR SYNERGY GLIDEPATH

    MDR report key: 3220830 · Received July 2, 2013

    Report

    Report Number
    3220830
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    A THORASCOPIC MAZE PROCEDURE WAS BEING PERFORMED TO TREAT PATIENT'S RECURRENT PAROXYSMAL ATRIAL FIBRILLATION FOLLOWING A CATHETER-BASED ABLATION SEVERAL YEARS AGO. SURGEON EXPERIENCED DIFFICULT EXPOSURE DUE TO LIMITED DEFLATION OF THE LUNG. AS SURGEON WAS USING THE EMR2 CLAMP, THE "RUBBER ATTACHMENT" FAILED AND CAME OFF OF THE INSTRUMENT. THE PIECE WAS RETRIEVED AND REMOVED. PROCEDURE WAS COMPLETED WITHOUT INJURY TO THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BILATERAL VIDEO-ASSISTED THORACOSCOPIC, MINIMALLY INVASIVE MAZE PROCEDURE (BILATERAL PULMONARY VEIN ABLATION, BILATERAL GANGLIONIC PLEXUS ABLATION, REMOVAL OF LEFT ATRIAL APPENDAGE)DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301441 ISOLATOR SYNERGY GLIDEPATH CARDIAC ABLATION SYSTEM OCL ATRICURE, INC. EMR2 41233

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR