BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO PTA BALLOON DILATATION CATHETER

    MDR report key: 1024286 · Received March 27, 2008

    Report

    Report Number
    2020394-2008-00061
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 3, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LIT
    PMA / PMN Number
    K072283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNKNOWN. 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 UNKNOWN. IT IS POSSIBLE THAT THIS EVENT WAS PROCEDURAL RELATED, HOWEVER, THIS COULD NOT BE CONFIRMED AS THE ROOT CAUSE. 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 FEMORAL THROUGH THE INTRODUCER SHEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTA OF THE FEMORAL ARTERY THE BALLOON WAS DIFFICULT TO REMOVE THROUGH A 6F SHEATH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A .035 GUIDEWIRE WAS USED DURING THE PROCEDURE. IT WAS NOTED THAT THE DOCTOR DID NOT USE A GENTLE COUNTERCLOCKWISE MOTION TO HELP FACILITATE THE CATHETER REMOVAL THROUGH THE INTRODUCER SHEATH AS RECOMMENDED IN PRODUCT LABELING. 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. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1