BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER CATHETER, DUO DECA LASSO CATHETER

    MDR report key: 1810691 · Received August 16, 2010

    Report

    Report Number
    MW5017117
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BIOSENSE WEBSTER CARDIAC CATHETER LASSO WAS CAUGHT ON THE MITRAL VALVE DURING CARDIAC ABLATION. DATES OF USE: (B)(6) 2010 - (B)(6) 2010. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER CATHETER, DUO DECA LASSO CATHETER CATHETER DRF BIOSENSE WEBSTER 115953

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR