BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERRATA

    MDR report key: 4289398 · Received November 25, 2014

    Report

    Report Number
    4289398
    Event Type
    Malfunction
    Date Received
    November 25, 2014
    Date of Event
    November 19, 2014
    Report Date
    November 25, 2014
    Manufacturer
    VOLCANO CORP
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    BOTH VOLCANO FFR (FRACTIONAL FLOW RESERVE) CABLES FAILED TO DEMONSTRATE ARTERIAL WAVEFORMS AFTER TROUBLESHOOTING. PATIENT WAS STARTED ON ANGIOMAX PER PROTOCOL FOR THIS PROCEDURE. PROCEDURE WAS RESCHEDULED FOR TOMORROW AND THIS REQUIRES PATIENT TO STAY OVERNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766317 VERRATA WIRE, GUIDE, CATHETER DQX VOLCANO CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR