BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN II HEMOSTASIS VALVE

    MDR report key: 2994808 · Received March 8, 2013

    Report

    Report Number
    3005395947-2013-00010
    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

    Additional Manufacturer Narrative · 1

    SUBMISSION OF THIS REPORT DOES NOT REPRESENT A CONCLUSION OR ADMISSION BY VASCULAR SOLUTIONS ZERUSA LIMITED THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE DEVICE FAILED OR MALFUNCTIONED IN ANY MANNER OR THAT THE DEVICES CAUSED OR CONTRIBUTED TO A DEATH. DEVICE NOT RETURNED TO MANUFACTURER.

    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
    100133 GUARDIAN II HEMOSTASIS VALVE HEMOSTASIS VALVE DTL VASCULAR SOLUTIONS ZERUSA LIMITED 8215 27660

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening