BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILTRAC

    MDR report key: 1192623 · Received September 29, 2008

    Report

    Report Number
    1192623
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ABBOTT VASCULAR DEVICES
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    AN AGILTRAC BALLOON WAS INFLATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) GRAFT THREE SEPARATE TIMES. AFTER THE THIRD INFLATION IT WAS NOTED THAT THE BALLOON HAD RUPTURED AND WAS CAUGHT ON THE END OF THE PINNACLE SHEATH STILL IN THE BODY. A PORTION OF THE BALLOON SHAFT WAS REMOVED FROM THE BODY. A BALLOON FROM ANOTHER MANUFACTURER WAS THEN INFLATED TO 6 ATMS AND THE FRACTURED BALLOON AND SHEATH WERE THEN REMOVED FROM THE BODY. A 6FR X 11 SHEATH WAS INSERTED INTO THE LEFT FEMORAL ARTERY AND THE CASE CONTINUED WITHOUT FURTHER INCIDENT. PT WAS DISCHARGED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILTRAC CATHETER, BALLOON DILATION LIT ABBOTT VASCULAR DEVICES N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR