BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER

    MDR report key: 1570732 · Received December 30, 2009

    Report

    Report Number
    MW5014153
    Event Type
    Injury
    Date Received
    December 30, 2009
    Date of Event
    December 15, 2009
    Report Date
    December 16, 2009
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    OAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN THE ELECTROPHYSIOLOGY LAB THE PT WAS BEING TREATED FOR ATRIAL FLUTTER, RIGHT SIDE. DURING THE CARTO RMT MAPPING AND ABLATION PHASE, THE CARTO DISPLAY FROZE FOR 2-3 SECONDS AND THE POSITION OF THE CATHETER COULD NOT BE VISUALIZED REALTIME. ABLATION WAS OCCURRING AT THE TIME THIS HAPPENED. WHEN THE SCREEN 'UNFROZE' IT WAS NOTED THAT THE CATHETER HAD MOVED A FEW MM'S, TO THE AV NODE AND BURNING HAD OCCURRED, PRODUCING COMPLETE HEART BLOCK. PT WILL BE DEPENDENT UPON A PACEMAKER DUE TO INADVERTENT ABLATION OF THE AV NODE. SERVICE RECORDS SHOW THAT THIS 'FREEZING OF THE CARTO SCREEN' HAS BEEN AN ISSUE ON SEVERAL OCCASIONS, TO WHICH BIOSENSE HAS INVESTIGATED AND HAS NOT BEEN ABLE TO REPRODUCE THE PROBLEM. HOWEVER, THIS IS THE ONLY REPORTED PT INJURY THAT WE HAVE ENCOUNTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER CARTO 3D CARDIAC MAPPING SYSTEM RMT OAD BIOSENSE WEBSTER R7033

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Disability