BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVC INSIGHT CATHETER

    MDR report key: 6971269 · Received October 24, 2017

    Report

    Report Number
    3004722468-2017-00002
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    August 17, 2017
    Report Date
    October 23, 2017
    Manufacturer
    INFRAREDX, INC.
    Product Code
    IYO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PERCUTANEOUS CORONARY INTERVENTION. DIAGNOSTIC IMAGING WITH COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. CATHETER WAS SUCCESSFULLY DELIVERED TO THE CORONARY ARTERY FOR IMAGING. RESISTANCE ENCOUNTERED WHEN ATTEMPTING TO REMOVE THE CATHETER FROM THE CORONARY ARTERY. OPERATOR CUT THE OUTER SHEATH OF THE CATHETER ON THE PROXIMAL END NEAR CONNECTION HUB TO FIRST REMOVE THE INNER CORE AND THEN REMOVE THE OUTER SHEATH SEPARATELY. NO INJURY TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754769 TVC INSIGHT CATHETER ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER IYO INFRAREDX, INC. TVC-C195-20 G37614

    Patients

    Seq Age Sex Outcome Treatment
    1