BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGIPRO 6-0

    MDR report key: 976342 · Received January 15, 2006

    Report

    Report Number
    976342
    Event Type
    Death
    Date Received
    January 15, 2006
    Date of Event
    January 19, 2005
    Report Date
    May 18, 2005
    Manufacturer
    US SURGICAL
    Product Code
    GAO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING VASCULAR PROCEDURE, ENDOVASCULAR WIRE ENTERED THE FEMORAL ARTERY. PT WAS TAKEN TO SURGERY FOR REMOVAL OF THE WIRE. FOLLOWING THE PROCEDURE, LEFT FEMORAL ARTERY PSEUDO ANEURYSM DEVELOPED AND RUPTURED. MD NOTES PATCH GRAFT SUTURE FAILURE CAUSING BREAKAGE. GRAFT BECAME INFECTED, PT BECAME SEPTIC AND DIED IN 2005. AUTOPSY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIPRO 6-0 SUTURE GAO US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death T3L189J 11/08| T2E94HT 5/07| T3J163J 9/08| LOT#'S AND EXP DATE RANGE: T2B322 2/07| T4H221J 8/09| T3278J 7/08