BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOOMERANG CATALYST II SYSTEM

    MDR report key: 1060270 · Received June 10, 2008

    Report

    Report Number
    3004182619-2008-00012
    Event Type
    Injury
    Date Received
    June 10, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 14, 2008
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    DXC
    PMA / PMN Number
    K072297
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BOOMERANG CATALYST II WAS DISCARDED AT THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER FOR EVAL. IT WAS REPORTED THE PRODUCT DEPLOYED AND DE-DEPLOYED AS INTENDED. REVIEW OF THE BATCH RECORD WAS UNABLE TO BE PERFORMED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED AND NO LONGER AVAILABLE. THE BCW PERFORMANCE WAS NOT CLINICALLY EVALUATED FOR GRAFTED ARTERIES.

    Description of Event or Problem · 1

    A PERIPHERAL INTERVENTIAL CASE WAS PERFORMED IN 2008, ON A FEMALE PT WITH PVD, HYPERTENSION, FEM-FEM BYPASS, GRAFTS IN BOTH FEMORAL ARTERIES, DIABETIC AND ARTERIOSTENOSIS. A 6 FR SHEATH WAS PLACED IN THE SYNTHETIC RIGHT FEMORAL COMMON ARTERY (RFCA) AND HEPARIN WAS ADMINISTERED. UPON COMPLETION OF THE PROCEDURE, A BOOMERANG CATALYST II WIRE (BCW) WAS INSERTED AND DEPLOYED THRU THE INDWELLING SHEATH W/O PROBLEM. TEMPORARY TAMPONADE OF THE ARTERIAL ACCESS WAS NOT ACHIEVED. THERE WAS CONSISTENT OOZING AROUND THE BCW. DWELL TIME WAS FOR 30 MINUTES TOTAL. PT BEGAN TO VOMIT. BCW WAS DEDEPLOYED AND REMOVED W/O INCIDENT. UPON REMOVAL, A HEMATOMA (>6 CM) STARTED TO FORM. FEMSTOP WAS APPLIED AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE FINAL HEMOSTASIS. TWO UNITS OF PACKED RED BLOOD CELL (PRBC) WAS ADMINISTERED. PT WAS ADMITTED FOR OBSERVATION. THE FOLLOWING DAY, PT WAS ADMINISTERED 1 UNIT OF PRBC. AT 3 DAYS POST OP, PT WAS DISCHARGED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG CATALYST II SYSTEM VASCULAR CLAMP DXC CARDIVA MEDICAL, INC. 500-580C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 6 FR SHEATH