BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEWIRE PRESTIGE PLUS

    MDR report key: 3646987 · Received February 21, 2014

    Report

    Report Number
    3646987
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    October 3, 2013
    Report Date
    February 21, 2014
    Manufacturer
    VOLCANO CORP
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    BOTH FFR WIRES WERE FLUSHED WITH 0.9% SALINE AND ZEROED BEFORE ENTERING THE PATIENT'S BODY. BEFORE CROSSING THE LESION, THE WIRES WERE EQUALIZED AND THE PRESSURE WAS AN ACCEPTABLE NUMBER. ONCE WE CROSSED THE LESION, ADENOSINE WAS STARTED AND THE MEASURING BEGAN. WE WATCHED THE FFR NUMBER INCREASE TO APPROXIMATELY 1.35 INSTEAD OF DECREASING BELOW 1.0. THE PHYSICIAN PULLED THE WIRE BACK INTO THE GUIDE AND THE WIRE WAS RE-EQUALIZED UNTIL IT REACHED THE ACCEPTABLE 1.0 VALUE. ONCE THE PHYSICIAN BEGAN MANIPULATING THE WIRE, THE WIRE NO LONGER SHOWED ANY PRESSURE MEASUREMENTS. THE WIRE WAS THEN REMOVED AND RE-ZEROED ACCORDING TO HOW WE WERE TAUGHT BY VOLCANO. ANY MOVEMENT OF THE WIRE, NO LONGER PICKED UP A WAVE FORM ON THE SCREEN. THE DECISION WAS MADE THAT THE WIRE MUST BE FAULTY, SO A NEW FFR WIRE OF THE SAME BRAND AND TYPE WAS OPENED. THE WIRE WAS FLUSHED WITH SALINE AND ZEROED BEFORE ENTERING THE BODY. THE NEW WIRE EQUALIZED CORRECTLY AND SHOWED A GOOD WAVEFORM.======================MANUFACTURER RESPONSE FOR PRIMEWIRE PRESTIGE PLUS, PRIMEWIRE PRESTIGE PLUS (PER SITE REPORTER).======================VENDOR REP WILL PICK UP FAILED DEVICE.======================MANUFACTURER RESPONSE FOR PRIMEWIRE PRESTIGE PLUS, PRIMEWIRE PRESTIGE PLUS (PER SITE REPORTER).======================VENDOR REP WILL PICK UP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110126 PRIMEWIRE PRESTIGE PLUS WIRE, GUIDE, CATHETER DQX VOLCANO CORP 9185 11050397002
    110127 PRIMEWIRE PRESTIGE PLUS WIRE, GUIDE, CATHETER DQX VOLCANO CORP 9185 011050000399032

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR