BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN II HEMOSTASIS VALVE

    MDR report key: 2983037 · Received February 28, 2013

    Report

    Report Number
    3005395947-2013-00001
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 28, 2013
    Manufacturer
    VASCULAR SOLUTIONS ZERUSA LIMITED
    Product Code
    DTL
    PMA / PMN Number
    K122301
    Removal / Correction Number
    3005395947-02/28/2013-01
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    DURING A CLINICAL PROCEDURE, AN AIR EMBOLISM WAS INTRODUCED WHILE USING A GUARDIAN II HEMOSTASIS VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86024 GUARDIAN II HEMOSTASIS VALVE HEMOSTASIS VALVE DTL VASCULAR SOLUTIONS ZERUSA LIMITED 8210 30238

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R