BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN II NC HEMOSTASIS VALVE

    MDR report key: 2438719 · Received February 3, 2012

    Report

    Report Number
    2134812-2012-00009
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    January 2, 2012
    Report Date
    February 3, 2012
    Manufacturer
    VASCULAR SOLUTIONS ZERUSA LIMITED
    Product Code
    DTL
    PMA / PMN Number
    K101113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE EXACT ROOT CAUSE OF THE FAILURE CANNOT BE DETERMINED. ATTEMPTS TO REPLICATE THE FAILURE SEEN IN THIS EVENT WERE UNSUCCESSFUL. DUE TO THE INABILITY TO RECREATE THE FAILURE, THE INVESTIGATION CONCLUDED THAT USER ERROR WAS THE POSSIBLE ROOT CAUSE FOR THE INTRODUCTION OF AIR INTO THE RCA. HOWEVER, AS THE PATIENT WAS HEMODYNAMICALLY STABLE FOLLOWING THE PROCEDURE, IT IS UNLIKELY THAT THE GUARDIAN II NC HEMOSTASIS VALVE CONTRIBUTED TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    THE GUARDIAN II NC HEMOSTASIS VALVE WAS USED ON A PATIENT EXPERIENCING AN ACUTE MYOCARDIAL INFARCTION. AN AIR BUBBLE ENTERED THE GUARDIAN II NC WHILE INSERTING A BALLOON. THE GUARDIAN II NC WAS LEAKING CONTRAST, AND DURING CONTRAST INJECTION, AN AIR BUBBLE WAS INTRODUCED INTO THE RIGHT CORONARY ARTERY. AFTER THE PROCEDURE, THE PATIENT WAS HEMODYNAMICALLY STABLE. THE PATIENT DIED THE NEXT DAY OF RIGHT HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN II NC HEMOSTASIS VALVE HEMOSTASIS VALVE DTL VASCULAR SOLUTIONS ZERUSA LIMITED 8216

    Patients

    Seq Age Sex Outcome Treatment
    1 Other