BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUALPRO¿ IVUS+NIRS IMAGING CATHETER

    MDR report key: 7826579 · Received August 29, 2018

    Report

    Report Number
    3004722468-2018-00002
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    August 1, 2018
    Report Date
    August 15, 2018
    Manufacturer
    INFRAREDX, INC.
    Product Code
    OGZ
    UDI-DI
    00857595006333
    PMA / PMN Number
    K163345
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PERCUTANEOUS CORONARY INTERVENTION. DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. A FIRST IMAGING CATHETER WAS USED TO SCAN A CORONARY ARTERY. A 90 DEGREE-SIZE WEDGE OF THE TRANSVERSE IVUS IMAGE WAS OBSERVED TO BE MISSING DURING THE SCAN. A SECOND CATHETER WAS TRIED AND A MISSING WEDGE OF THE TRANSVERSE IVUS IMAGE WAS AGAIN OBSERVED DURING THE SCAN. A DIFFERENT BRAND OF IVUS IMAGING CATHETER WAS THEN USED TO SCAN THE VESSEL. A DISSECTION OF THE VESSEL WAS OBSERVED DURING SCANNING AND A STENT WAS DEPLOYED TO TREAT IT. WHILE THE NIRS-IVUS CATHETER WAS NOT DEEMED TO BE THE DIRECT CAUSE OF PATIENT HARM, FAILURE OF THE IVUS IMAGING WITH THE NIRS-IVUS CATHETER COMPLICATED THE PROCEDURE AND MAY HAVE CONTRIBUTED TO USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671392 DUALPRO¿ IVUS+NIRS IMAGING CATHETER ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER OGZ INFRAREDX, INC. TVC-C195-42 804191 00857595006333

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention