BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 1052839 · Received May 27, 2008

    Report

    Report Number
    2020394-2008-00142
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Report Date
    April 24, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LIT
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED, AND IT WAS CONFIRMED THAT THE LOT MET ALL RELEASE CRITERIA. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFO RECEIVED, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNK. THE CURRENT IFU STATES: POSITION THE BALLOON RELATIVE TO THE LESION TO BE DILATED, ENSURE THE GUIDEWIRE IS IN PLACE AND INFLATE THE BALLOON TO THE APPROPRIATE PRESSURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A SUCCESSFUL ANGIOPLASTY OF THE LEFT ILIAC ARTERY, THE PTA BALLOON DETACHED FROM THE SHAFT AS IT WAS BEING REMOVED. THE BALLOON WAS REMOVED WITH THE 6F SHEATH. THIS WAS A RIGHT FEMORAL APPROACH, GOING UP AND OVER THE BIFURCATION TO THE LEFT SIDE ILIAC ARTERY. A .035 WIRE WAS USED. NO INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORADO PTA BALLOON DILATATION CATHETER LIT BARD PERIPHERAL VASCULAR, INC. 93AS0161

    Patients

    Seq Age Sex Outcome Treatment
    1