BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICTORY

    MDR report key: 2945115 · Received January 31, 2013

    Report

    Report Number
    3006010712-2013-00005
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 31, 2013
    Manufacturer
    BRIVANT, LTD.
    Product Code
    DQX
    PMA / PMN Number
    K120137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE GUIDEWIRE AND CATHETER DEVICE WERE RETURNED AS ONE UNIT. IT WAS CONFIRMED THAT THE GUIDEWIRE WAS STUCK IN THE CATHETER. EVIDENCE OF POLYMER JACKET SEPARATION WAS FOUND ON THE WIRE. THIS LIKELY TO HAVE CONTRIBUTED TO THE FRICTION EXPERIENCED BY THE USER BETWEEN THE GUIDEWIRE AND THE CATHETER. THE FAILURE MODE OF POLYMER JACKET SEPARATION HAS BEEN REVIEWED AGAINST REPORTING CRITERIA AND IT IS CONSIDERED TO BE A REPORTABLE EVENT. THE FINAL INVESTIGATION REPORT HAS BEEN SUBMITTED TO OUR INTERNAL DESIGN ENGINEER FOR REVIEW AND A FINAL MDR WILL BE SUBMITTED. UPON APPROVAL.

    Description of Event or Problem · 1

    ANATOMY DESCRIPTION: PERONEAL ARTERY OCCLUSION WITH A MEDIUM LEVEL OF CALCIFICATION. THE TERUMO STIFF (0.035") GUIDEWIRE WAS USED TO CROSS A POPLITEAL STENOSIS. THE TERUMO GUIDEWIRE WAS THEN REMOVED AND A VICTORY 0.014" GUIDEWIRE WAS INSERTED IN THE IMAGER II CATHETER IN ATTEMPT TO CROSS THE OCCLUSION ON THE PERONEAL ARTERY. THE VICTORY GUIDEWIRE CROSSED THE OCCLUSION WITHOUT ISSUE. THE COYOTE OTW WAS INSERTED ON THE VICTORY GUIDEWIRE. DILATATION WITH THE BALLOON WAS PERFORMED. AFTER DILATATION, THE PHYSICIAN WANTED TO REMOVE THE COYOTE BALLOON CATHETER BUT THE COYOTE COULD NOT BE RETRACTED. THERE WAS A VERY STRONG FRICTION BETWEEN THE GUIDEWIRE AND THE INNER LUMEN OF THE BALLOON. IT WAS IMPOSSIBLE TO REMOVE COYOTE FROM THE GUIDEWIRE, SO THE PHYSICIAN WAS CONSTRAINED TO REMOVE COYOTE AND VICTORY TOGETHER. NO PIECES OF GUIDEWIRE REMAINED IN THE BODY; NO PROBLEM ON PT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42294 VICTORY GUIDEWIRE DQX BRIVANT, LTD. 901023-30 10171169

    Patients

    Seq Age Sex Outcome Treatment
    1 Other