BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOOMERANG CATALYST II SYSTEM

    MDR report key: 1060658 · Received June 10, 2008

    Report

    Report Number
    MW5007288
    Event Type
    Injury
    Date Received
    June 10, 2008
    Date of Event
    May 7, 2008
    Report Date
    June 10, 2008
    Manufacturer
    CARDIVA MEDICAL INCORPORATED
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD CARDIAC CATH IN 2008, IN WHICH A CLOSURE DEVICE WAS USED TO CLOSE THE FEMORAL ARTERY. THE DEVICE WAS A BOOMERANG CATALYST II SYSTEM MODEL #500-580C. THE PATIENT RETURNED AT APPROXIMATELY THREE WEEKS LATER - WITH CLAUDICATION OF RIGHT LEG AFTER DOPPLER STUDY SHOWED OCCLUSION OF THE FEMORAL ARTERY. STENTS WERE REQUIRED AT SITE OF OCCLUSION WHICH WAS SITE OF ORIGINAL CATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG CATALYST II SYSTEM CLOSURE DEVICE MGB CARDIVA MEDICAL INCORPORATED NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability