BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSEAL

    MDR report key: 1003927 · Received January 31, 2008

    Report

    Report Number
    1003927
    Event Type
    Malfunction
    Date Received
    January 31, 2008
    Date of Event
    November 18, 2007
    Report Date
    January 31, 2008
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEPLOYMENT OF THE ANGIOSEAL DISSOLVABLE VASCULAR CLOSURE PLUG FAILED. THE ANGIOSEAL PERFORMED PER PROTOCOL, WITH NO APPARENT DIFFICULTY. THE SUTURE WAS CUT, BUT HEMOSTASIS WAS NOT OBTAINED. MANUAL PRESSURE WAS APPLIED TO CONTROL BLEEDING FOR 15 MINUTES. PATIENT WAS WELL ANTICOAGULATED DURING PROCEDURE. A "C CLAMP" WAS THEN UTILIZED TO ACHIEVE HEMOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSEAL VASCULAR CLOSURE DEVICE MGB ST. JUDE MEDICAL, INC. 6 FRENCH, VIP NOT LISTED

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR