BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOOMERANG

    MDR report key: 830741 · Received March 16, 2007

    Report

    Report Number
    3004182619-2007-00006
    Event Type
    Other
    Date Received
    March 16, 2007
    Date of Event
    March 2, 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

    Additional Manufacturer Narrative · 1

    TWO USER / PHYSICIAN'S FROM THE SITE INDICATED THIS EVENT WAS NOT AS A RESULT OF THE USE OF THE BOOMERANG DEVICE.

    Description of Event or Problem · 1

    PATIENT SUFFERED A PSUEDOANEURYSM 2 DAYS AFTER A BRACHIAL CASE. DR. INJECTED PSUEDOANEURYSM AND PATIENT IS FINE AND RETURNED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG BOOMERANG 56 MGB CARDIVA MEDICAL, INC. BOOMERANG 56 56070108A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| R