BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER SOUNDSTAR 3D

    MDR report key: 1678199 · Received May 9, 2010

    Report

    Report Number
    1678199
    Event Type
    Malfunction
    Date Received
    May 9, 2010
    Date of Event
    January 15, 2010
    Report Date
    May 9, 2010
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER WOULD NOT DEFLECT PROPERLY. IT WAS REPROCCESSED THROUGH ASCENT CORP. THEY NEED TO BE AWARE OF THIS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER SOUNDSTAR 3D CATHETER, INTRAVASCULAR ULTRASOUND OBJ ASCENT HEALTHCARE SOLUTIONS * SNDSTR10

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR