BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOOMERANG 56

    MDR report key: 650161 · Received December 5, 2005

    Report

    Report Number
    3004182619-2005-00002
    Event Type
    Other
    Date Received
    December 5, 2005
    Date of Event
    November 18, 2005
    Report Date
    December 5, 2005
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DIAGNOSTIC PROCEDURE IN 2005. THE PHYSICIAN HAD DIFFICULTY ACCESSING THE SITE DUE TO THE PT BODY MASS. POST PROCEDURE, THE PHYSICIAN DEPLOYED THE BOOMERANG, DWELL TIME WAS 20 MINUTES AND THE HOLD TIME WAS 5 MINUTES. HEMOSTASIS ACHIEVED. ONE DAY LATER VASCULAR SURGERY WAS PERFORMED DUE TO A RETROPERITONEAL BLEED. THERE WAS A TEAR ON A SMALL BRANCH OFF THE FEMORAL ARTERY, AT/NEAR THE FEMORAL HEAD. PT STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG 56 VASCULAR CLOSURE DEVICE MGB CARDIVA MEDICAL, INC. BOOMERANG 56 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention