BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOOMERANG

    MDR report key: 827563 · Received March 5, 2007

    Report

    Report Number
    3004182619-2007-00002
    Event Type
    Other
    Date Received
    March 5, 2007
    Date of Event
    December 7, 2006
    Report Date
    March 5, 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 INDICATED THIS EVENT WAS NOT AS A RESULT OF THE USE OF THE BOOMERANG DEVICE. ADDITIONAL INFORMATION (2/22/07) - USER FACILITY CONTACTED CARDIVA MEDICAL ON 2/22/2007 TO INDICATE THAT THEY WANTED IT NOTED ON THE MDR THAT THE PATIENT EXPIRING WAS COMPLETELY NON RELATED TO THE BOOMERANG DEVICE AND THE SURGICAL PROCEDURE WHICH TOOK PLACE USING THE BOOMERANG DEVICE.

    Description of Event or Problem · 1

    PATIENT UNDERWENT PROCEDURE WITH SUCCESSFUL BOOMERANG PLACEMENT. UPON TRANSPORT OF PATIENT TO POST OP AREA, PATIENT'S BELLY APRON DISLODGED BOOMERANG. DWELL TIME WAS APPROXIMATELY 20 MINUTES. PSEUDOANEURYSM WAS NOTED, NECK SIZE 0.3 CM, (1.5CM X 0.9CM) IN THE RIGHT GROIN AREA, ALSO HEMATOMA. DIFFICULT TO COMPRESS. PATIENT DISCHARGED IN 2006, RETURNED EARLY A.M. OF THE FOLLOWING DAY IN SHOCK. TRANSFUSION GIVEN (4 UNITS). PSEUDOANEURYSM SIZE UPON RETURN - 1.7 CM X 1.2 CM (NECK SIZE 5 MM). PATIENT HAD ACUTE RENAL AND LIVER FAILURE. PATIENT HAD CARDIAC ARREST/CODE BLUE SIX DAYS LATER, EXPIRED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG BOOMERANG 610 MGB CARDIVA MEDICAL, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R