BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN II NC HEMOSTASIS VALVE

    MDR report key: 2994327 · Received March 8, 2013

    Report

    Report Number
    3005395947-2013-00004
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    January 14, 2013
    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
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL PROCEDURE WHERE THE GUARDIAN II NC HEMOSTASIS VALVE WAS USED, THE PATIENT EXPERIENCED CHEST PAIN (10 OF 10 PAIN LEVEL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100199 GUARDIAN II NC HEMOSTASIS VALVE HEMOSTASIS VALVE DTL VASCULAR SOLUTIONS ZERUSA LIMITED 8215 30126

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening