BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOOMERANG

    MDR report key: 841265 · Received April 11, 2007

    Report

    Report Number
    3004182619-2007-00007
    Event Type
    Other
    Date Received
    April 11, 2007
    Date of Event
    March 1, 2007
    Report Date
    April 10, 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

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

    Description of Event or Problem · 1

    PT SUFFERED A PSEUDOANEURYSM WITHIN A WEEK OF THE PROCEDURE. THE ACCESS SITE WAS GRAFT MADE OF DACRON MATERIAL. BOOMERANG IS NOT TO BE USED DUE TO THE GRAFT. DAYS AFTER THE PROCEDURE, PT RETURNED WITH A 2 CM PSEUDOANEURYSM. THE PSEUDOANEURYSM WAS RESOLVED WITH 20 MINUTES OF COMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG BOOMERANG 58 MGB CARDIVA MEDICAL, INC. BOOMERANG 58 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other| R