BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOOMERANG CATALYST II SYSTEM

    MDR report key: 1420689 · Received July 24, 2009

    Report

    Report Number
    1420689
    Event Type
    Death
    Date Received
    July 24, 2009
    Date of Event
    April 29, 2009
    Report Date
    July 23, 2009
    Manufacturer
    CARDIVA MEDICAL INC
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELDERLY MALE PATIENT IMMEDIATELY STATUS POST CARDIAC CATH WITH STENT PLACEMENT X2 MARGINAL BRANCH OF CIRCUMFLEX ARTERY. DEPLOYMENT OF BOOMERANG CLOSURE ASSIST DEVICE. PATIENT BECAME UNRESPONSIVE AFTER TRANSFER TO INPATIENT BED. DID NOT RESPOND TO ACLS. EXPIRED. AUTOPSY SHOWING DISLODGEMENT OF FEMORAL ARTERY CLOSURE DEVICE AND MASSIVE RETROPERITONEAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG CATALYST II SYSTEM VASCULAR CLOSURE DEVICE MGB CARDIVA MEDICAL INC 500-580C *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death CARDIAC DRUGS| CARDIAC DRUGS