BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUALPRO¿ IVUS+NIRS IMAGING CATHETER

    MDR report key: 8716639 · Received June 20, 2019

    Report

    Report Number
    3004722468-2019-00002
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    May 23, 2019
    Report Date
    June 19, 2019
    Manufacturer
    INFRAREDX, INC.
    Product Code
    OBJ
    UDI-DI
    00857595006135
    PMA / PMN Number
    K163345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. IT IS REPORTED THAT THERE WAS SOME DIFFICULTY WITHDRAWING THE IMAGING CATHETER FROM THE CORONARY ARTERY. THE IMAGING CATHETER WAS THEREFORE REMOVED FROM THE PATIENT WITH THE GUIDEWIRE (SION BLUE, ASAHI-INTECC). IT IS REPORTED THERE WAS STILL SOME DIFFICULTY WHEN WITHDRAWING THE GUIDEWIRE FROM THE IMAGING CATHETER. NO INJURY TO PATIENT REPORTED. NO TREATMENT OF PATIENT REQUIRED DUE TO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508691 DUALPRO¿ IVUS+NIRS IMAGING CATHETER ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER OBJ INFRAREDX, INC. TVC-C195-42 807254-A 00857595006135

    Patients

    Seq Age Sex Outcome Treatment
    1