BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 1053478 · Received May 28, 2008

    Report

    Report Number
    2020394-2008-00144
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Report Date
    May 6, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LIT
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS NOT BEEN RETURNED FOR EVAL, SO A SAMPLE EVAL COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNK. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNK. THE CURRENT IFU STATES: IF RESISTANCE IS FELT DURING POST PROCEDURE WITHDRAWAL OF THE CATHETER, IT IS RECOMMENDED TO REMOVE THE BALLOON CATHETER AND GUIDEWIRE/INTRODUCER SHEATH AS A SINGLE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PTA BALLOON DEVICE WAS DIFFICULT TO REMOVE. THE PHYSICIAN HAD COMPLETED A SUCCESSFUL PTA OF AN ILIAC VEIN, USING A FEMORAL APPROACH. A 6F SHEATH AND A 0.035 GUIDE WIRE WERE USED IN THE PROCEDURE. THE BALLOON WAS INFLATED ONLY ONCE TO 18ATMS USING AN INFLATION DEVICE, BUT IT IS UNK HOW LONG IT WAS HELD. AFTER THE COMPLETION OF THE PROCEDURE, THE BALLOON AND THE SHEATH HAD TO BE REMOVED TOGETHER. NO REPORTED INJURY TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1