BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPERWIRE

    MDR report key: 1883410 · Received October 4, 2010

    Report

    Report Number
    1883410
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 4, 2010
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    WHILE REMOVING THROUGH THE ARTERIAL SHEATH, THE VIPERWIRE GUIDEWIRE UNRAVELED AND BROKE OFF IN SHEATH. ALL WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPERWIRE GUIDEWIRE DQX CARDIOVASCULAR SYSTEMS INCORPORATED VPR-GW-14 35420

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR