BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOOMERANG 610

    MDR report key: 677121 · Received February 14, 2006

    Report

    Report Number
    3004182619-2006-00002
    Event Type
    Other
    Date Received
    February 14, 2006
    Date of Event
    January 26, 2006
    Report Date
    February 14, 2006
    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

    PHYSICIAN ATTEMPTED TO REINSERT AN 8F SHEATH OVER THE 610 DEVICE AND TORE THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG 610 VASCULAR CLOSURE DEVICE MGB CARDIVA MEDICAL, INC. 610 610060113A

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention