BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER

    MDR report key: 1876485 · Received October 14, 2010

    Report

    Report Number
    MW5017810
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 14, 2010
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE MAPPING THE LEFT ATRIUM AND PULMONARY VEINS WITH A BIOSENSE CATHETER, THE TIP OF THE CATHETER BECAME STUCK IN THE MITRAL VALVE. THE CATHETER WAS CAREFULLY DISLODGED AND THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER LASSO CATHETER DQO DL71015RT 15230699L

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other