BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN II NC HEMOSTASIS VALVE

    MDR report key: 2994782 · Received March 8, 2013

    Report

    Report Number
    3005395947-2013-00011
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    September 24, 2012
    Report Date
    March 8, 2013
    Manufacturer
    VASCULAR SOLUTIONS ZERUSA LIMITED
    Product Code
    DTL
    PMA / PMN Number
    K122301
    Removal / Correction Number
    3005395947-02/28/2013-01
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIANS NOTED AIR IN THE GUARDIAN II HEMOSTASIS VALVE AFTER INTRODUCING BALLOON OR GUIDEWIRE, NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98871 GUARDIAN II NC HEMOSTASIS VALVE HEMOSTASIS VALVE DTL VASCULAR SOLUTIONS ZERUSA LIMITED 8215 28247

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening