BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 1024289 · Received March 27, 2008

    Report

    Report Number
    2020394-2008-00058
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LIT
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 EVAL AS IT WAS DISCARDED BY THE USER FACILITY. BASED ON THE INFO RECEIVED, THE RESULTS ARE INCONCLUSIVE AND THE ROOT CAUSE OF THE EVENT 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. WHILE MAINTAINING NEGATIVE PRESSURE AND THE POSITION OF THE GUIDEWIRE, WITHDRAW THE DEFLATED DILATATION CATHETER OVER THE WIRE THROUGH THE INTRODUCER SHEATH. USE OF A GENTLE COUNTERCLOCKWISE MOTION MAY BE USED TO HELP FACILITATE CATHETER REMOVAL THROUGH THE INTRODUCER SHEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALTHOUGH THE OUTCOME OF THE PTA PROCEDURE WAS GOOD, IT WAS DIFFICULT TO REMOVE THE BALLOON FROM THE 7F CROSSOVER SHEATH. A "LONGER" INFLATION TIME WAS ALSO REPORTED. THE PROCEDURE WAS A PERIPHERAL PROCEDURE OF THE LEG. A .035 GUIDEWIRE WAS USED AND IT WAS NOTED THAT THE BALLOON WAS INFLATED ONE TIME ONLY FOR 20 SECONDS. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORADO PTA BALLOON DILATATION CATHETER LIT BARD PERIPHERAL VASCULAR, INC. 93IR0024

    Patients

    Seq Age Sex Outcome Treatment
    1