BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILTRAC .035 PERIPHERAL DILATATION CATHETER

    MDR report key: 708667 · Received May 2, 2006

    Report

    Report Number
    3004742046-2006-00204
    Event Type
    Malfunction
    Date Received
    May 2, 2006
    Date of Event
    April 13, 2006
    Report Date
    April 13, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    LIT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TREATING A HEAVILY TORTUOUS AND CALCIFIED ILIAC, 2 A GILTRACS, PART NUMBER 1010007-20 WERE USED, 1 IN THE LEFT BIFURCATED AND 1 IN THE RIGHT BIFURCATION. THE AGILTRAC BALLOON IN THE LEFT RUPTURED AT 8ATM. THIS RUPTURED BALLOON WAS REMOVED WITHOUT INCIDENT. WITH THE 1010007-20 REMAINING IN THE RIGHT ILIAC A 1010008-20 AGILTRAC BALLOON WAS PLACED IN THE LEFT AND THIS BALLOON RUPTURED AT 6 ATM. THIS DEVICE WAS ALSO REMOVED WITHOUT INCIDENT AND INJURY OR EFFECT TO THE PT. A NON-GUIDANT 9MM STENT WAS PLACED IN THE LESION WITHOUT INCIDENT. THE PHYSICIAN FELT THE BALLOONS RUPTURED DUE TO THE HEAVY TORTUOUSITY AND CALCIFICATION. IT IS NOTED THIS PRODUCT (1010008-20) WAS EXPIRED WHEN USED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILTRAC .035 PERIPHERAL DILATATION CATHETER PERIPHERAL DILATATION CATHETER LIT GUIDANT ENDOVASCULAR SOLUTIONS NA 4030451

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR