BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOOMERANG

    MDR report key: 940173 · Received November 6, 2007

    Report

    Report Number
    3004182619-2007-00016
    Event Type
    Injury
    Date Received
    November 6, 2007
    Date of Event
    October 22, 2007
    Report Date
    November 6, 2007
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    K061075
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORMING PHYSICIAN DOES NOT BELIEVE THE DEVICE CONTRIBUTED TO THE INJURY AND THERE WERE NO MALFUNCTIONS. LOCATION OF INJURY IS DISTAL TO THE COMMON FEMORAL ARTERY. THE LOT NUMBER TO THE DEVICE WAS NOT DOCUMENTED AT THE HOSPITAL. THERE WERE 2 LOTS DELIVERED TO THIS SITE: 580070416A AND 580061228A. BOTH BATCH RECORDS WERE REVIEWED AND ALL DEVICES RELEASED PASSED FINAL QC INSPECTION & TESTING. LOT 580070416A EXPIRES ON MARCH 2009 AND LOT 580061228A EXPIRES ON NOVEMBER 2008.

    Description of Event or Problem · 1

    PATIENT UNDERWENT DIAGNOSTIC PROCEDURE - BOOMERANG 200-580 WAS USED. HEMOSTASIS WAS ACHIEVED WITH A 9 MINUTE DWELL AND 6 MINUTE MANUAL COMPRESSION HOLD. PATIENT WAS TRANSPORTED TO RECOVERY ROOM WHERE UPON ARRIVAL, A SMALL HEMATOMA WAS PALPATED BY THE NURSE. MANUAL COMPRESSION WOULD NOT RESOLVE THE HEMATOMA. SURGERY WAS PERFORMED TO REPAIR A SMALL TEAR IN THE EXTERNAL ILIAC, A LOCATION DISTAL TO THE PROCEDURAL SHEATH/ DEVICE ACCESS SITE IN THE COMMON FEMORAL ARTERY AND WHERE MANUAL COMPRESSION WAS APPLIED. PATIENT RECOVERED UNEVENTFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG VASCULAR CLOSURE DEVICE MGB CARDIVA MEDICAL, INC. 200-580 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention