BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUALPRO IVUS + NIRS IMAGING CATHETER

    MDR report key: 7177199 · Received January 9, 2018

    Report

    Report Number
    3004722468-2017-00004
    Event Type
    Malfunction
    Date Received
    January 9, 2018
    Date of Event
    December 12, 2017
    Report Date
    January 9, 2018
    Manufacturer
    INFRAREDX, INC.
    Product Code
    OGZ
    UDI-DI
    00857595005234
    PMA / PMN Number
    163345
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PERCUTANEOUS CORONARY INTERVENTION OF THE RIGHT CORONARY ARTERY (RCA). DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. DIFFICULTY ENCOUNTERED IN REMOVING THE CATHETER FROM THE ARTERY AFTER SCANNING THE STENTED LESION. PRE-STENT: CATHETER CROSSED HEAVILY CALCIFED LESION SMOOTHLY. POST-STENT (3.00 X 38 MM): ATTEMPTED TO SCAN STENTED LESION WITH IMAGING CATHETER. CATHETER BECAME STUCK IN STENTED CORONARY ARTERY. UNABLE TO INSERT BALLOON OR MICRO-CATHETER TO REMOVE IMAGING CATHETER. USED EXTRA FLOPPY GUIDEWIRE TO SUCCESSFULLY REMOVE THE IMAGING CATHETER FROM THE CORONARY ARTERY. REVIEW OF ANGIOGRAPHIC AND NIRS-IUVS DATA SUGGESTS THAT A SEGMENT OF UNDER-EXPANDED STENT MAY HAVE CONTRIBUTED TO THE IMAGING CATHETER BECOMING STUCK IN THE STENTED CORONARY ARTERY. NO INJURY TO PATIENT REPORTED. NO TREATMENT OF PATIENT REQUIRED DUE TO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20841 DUALPRO IVUS + NIRS IMAGING CATHETER ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER, PRODUCT OGZ INFRAREDX, INC. TVC-C195-42 709142 00857595005234

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention