BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUALPRO IVUS+NIRS IMAGING CATHETER

    MDR report key: 10329292 · Received July 27, 2020

    Report

    Report Number
    3015551113-2020-00002
    Event Type
    Malfunction
    Date Received
    July 27, 2020
    Date of Event
    July 8, 2020
    Report Date
    July 27, 2020
    Manufacturer
    INFRAREDX, INC.
    Product Code
    OGZ
    UDI-DI
    00857595006241
    PMA / PMN Number
    K163345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. IVUS IMAGES WERE LOST DURING USE POST STENT DEPLOYMENT. THE CATHETER BECAME ENTANGLED IN THE STENT DURING INSERTION AND STEPS TAKEN TO REMEDIATE THE SITUATION MAY HAVE DAMAGED THE IVUS IMAGING FUNCTION OF THE CATHETER. NO PATIENT INJURY REPORTED. NO TREATMENT OF PATIENT REQUIRED DUE TO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789044 DUALPRO IVUS+NIRS IMAGING CATHETER ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER OGZ INFRAREDX, INC. TVC-C195-42 DPY191031A 00857595006241

    Patients

    Seq Age Sex Outcome Treatment
    1