BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE AERIS

    MDR report key: 4202399 · Received September 30, 2014

    Report

    Report Number
    4202399
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 16, 2014
    Report Date
    September 29, 2014
    Manufacturer
    ST JUDE MEDICAL INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN AERIS PRESSURE WIRE WAS USED TO DETERMINE THE DEGREE OF STENOSIS FOR AN OFFENDING LESION IN CARDIOVASCULAR INTERVETNIONAL RADIOLOGY. THE INITIAL WIRE USED FAILED DESPITE PROPER SETUP AND TROUBLE SHOOTING. A SECOND WIRE FUNCTIONED PROPERLY AND THE PROCEDURE WAS COMLETED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606855 PRESSUREWIRE AERIS AERIS PRESSURE WIRE DQX ST JUDE MEDICAL INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR