BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOOMERANG 610

    MDR report key: 822560 · Received February 20, 2007

    Report

    Report Number
    3004182619-2007-00003
    Event Type
    Other
    Date Received
    February 20, 2007
    Date of Event
    November 28, 2006
    Report Date
    February 20, 2007
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PERIPHERAL INTERVENTION, 8 FR SHEATH, ANGIOMAX AND INTEGRILIN DRIP. TEMPORARY HEMOSTASIS WAS NOT ACHIEVED. TECH HELD PROXIMAL PRESSURE FOR 30 MINUTES, PHYSICIAN RETURNED TO OBSERVE SITE, HELD PROXIMAL PRESSURE FOR 10 MINUTES. HEMOSTASIS WAS NOT ACHIEVED, SO SHEATH REINTRODUCED. RETROPERITONEAL BLEED WAS OBSERVED. TWO UNITS OF BLOOD AND DOPAMINE DRIP ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG 610 VASCULAR CLOSURE DEVICE MGB CARDIVA MEDICAL, INC. BOOMERANG 610 610061002A

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other