BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUALPRO¿ IVUS+NIRS IMAGING CATHETER

    MDR report key: 7696102 · Received July 17, 2018

    Report

    Report Number
    3004722468-2018-00001
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    June 28, 2018
    Report Date
    July 13, 2018
    Manufacturer
    INFRAREDX, INC.
    Product Code
    OGZ
    UDI-DI
    00857595006234
    PMA / PMN Number
    K163345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PERCUTANEOUS CORONARY INTERVENTION. DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. AFTER PERFORMING A 5TH SCAN WITH THE IMAGING CATHETER, IT WAS REPORTED THAT IT WAS DIFFICULT TO WITHDRAW THE CATHETER FROM THE VESSEL. SEVERAL APPROACHES WERE TAKEN TO REMOVE THE CATHETER, INCLUDING 1-PUSHING AND PULLING THE CATHETER, 2- INSERTING A BALLOON OR MICRO CATHETER ADJACENT TO THE IMAGING CATHETER, 3- TRANSLATING THE IMAGING CORE PROXIMALLY (DURING LIVE IVUS IMAGING), AND 4- CUTTING THE SHEATH TO REMOVE THE IMAGING CORE AND INSERTING A 0.018" GUIDEWIRE. THE LATTER APPROACH WAS ULTIMATELY SUCCESSFUL IN REMOVING THE IMAGING CATHETER FROM THE VESSEL. NOTE THAT IVUS IMAGING WAS LOST AND THE IMAGING CORE WAS NEARLY DETACHED IN THE COURSE OF ATTEMPTING TO WITHDRAW THE CATHETER. A REVIEW OF THE IVUS DATA INDICATES THAT A STENT WAS DEPLOYED IN THE MID/DISTAL VESSEL AND ANOTHER OVERLAPPING STENT WAS DEPLOYED IN THE PROXIMAL VESSEL DURING THE PROCEDURE PRIOR TO THE CATHETER BECOMING STUCK. IVUS IMAGES OF THE SECOND STENT SUGGEST THAT THE STENT WAS MAL-APPOSED TO THE VESSEL WALL. THIS MAL-APPOSITION MAY HAVE CAUSED THE IMAGING CATHETER TO BECOME STUCK IN THE STENTED VESSEL. NO INJURY TO PATIENT REPORTED. NO TREATMENT OF PATIENT REQUIRED DUE TO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535441 DUALPRO¿ IVUS+NIRS IMAGING CATHETER ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER OGZ INFRAREDX, INC. TVC-C195-42 803201 00857595006234

    Patients

    Seq Age Sex Outcome Treatment
    1