BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI TORQUE CONNECT GUIDEWIRE

    MDR report key: 3102011 · Received May 3, 2013

    Report

    Report Number
    3006010712-2013-00020
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 2, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BRIVANT, LTD.
    Product Code
    DQX
    PMA / PMN Number
    K112381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RIGHT FEMORAL ACCESS (NO CROSS-OVER). LONG CALCIFIC AND STENOTIC LESION LOCATED IN THE RIGHT ANTERIOR TIBIAL ARTERY. THE HT CONNECT GUIDE WIRE REACHED THE LESION WITHOUT DIFFICULTY. A BALLOON (CORDIS 2.5X220 MM) WAS USED TO TREAT THE LESION. THE BALLOON WAS SUCCESSFULLY INFLATED AND DEFLATED. THE PHYSICIAN WANTED TO RETRIEVE THE GUIDE WIRE AND LEAVE THE BALLOON IN THE PT ANATOMY TO INFLATE SOME CONTRAST. WHILE ATTEMPTING THIS ACTION SOME RESISTANCE WAS FELT BECAUSE THE TIP OF THE GUIDE WIRE MADE A LOOP AND FIXED INTO THE TIP OF THE BALLOON ITSELF. THE GUIDE WIRE AND THE BALLOON WERE RETRIEVED AS A SINGLE UNIT. OUT OF THE PT IT WAS NOTED THAT THE GREEN COVERING OF THE GUIDE WIRE WAS PARTIALLY DAMAGED (PARTIALLY DETACHED). THE PROCEDURE WAS SUCCESSFULLY CONCLUDED BY USING A COMMAND GUIDE WIRE AND AN ARMADA 14 BALLOON. THERE WAS NOT SIGNIFICANT IMPACT TO THE PT DUE TO DELAY IN THE PROCEDURE, NO CLINICALLY SIGNIFICANT. NO MEDICATION GIVEN TO THE PT DUE TO ISSUE WITH THE USE OF OUR DEVICES. PT INFO CAN NOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194828 HI TORQUE CONNECT GUIDEWIRE GUIDEWIRE DQX BRIVANT, LTD. 901022-02 10087179

    Patients

    Seq Age Sex Outcome Treatment
    1 Other