BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOOMERANG

    MDR report key: 751320 · Received August 10, 2006

    Report

    Report Number
    3004182619-2006-00010
    Event Type
    Other
    Date Received
    August 10, 2006
    Date of Event
    July 31, 2006
    Report Date
    August 10, 2006
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    K041486
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN INDICATED TO CARDIVA THAT DIDN'T BELIEVE THE BOOMERANG WAS THE CAUSE OF THE INCIDENT. HE FELT THE PATIENT HAD A HIGH BACK-WALL STICK FOR WHICH THE BOOMERANG IS NOT MEANT TO CLOSE.

    Description of Event or Problem · 1

    BOOMERANG WIRE WAS PLACED POST DIAGNOSTIC PROCEDURE WITHOUT PROBLEM: TEMPORARY HEMOSTASIS WAS ACHIEVED: NO OOZING: PRESSURE HELD AND NO APPARENT SIGNS OF HEMATOMA. AFTER 6 HOURS OF LAYING FLAT, PATIENT COMPLAINED OF SEVERE ABDOMINAL PAIN WHEN ATTEMPTING TO AMBULATE. PATIENT WAS ADMITTED AND AFTER DIAGNOSTIC PROCEDURE IT WAS DETERMINED THAT THE PATIENT NEEDED SURGICAL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG VASCULAR CLOSURE DEVICE MGB CARDIVA MEDICAL, INC. 56 66060620A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention