BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVC INSIGHT CATHETER

    MDR report key: 3954760 · Received July 18, 2014

    Report

    Report Number
    3004722468-2014-00001
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 17, 2014
    Manufacturer
    INFRAREDX INC.
    Product Code
    OGZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH MODERATE TO SEVERE CIRCUMFLEX LESION BY ANGIO AND IVUS. NO OTHER SEVERE CORONARY DISEASE. LEFT HEART CATH, CORONARY ANGIOS PERFORMED PERCUTANEOUSLY VIA RIGHT GROIN. IVUS OF CIRCUMFLEX TO ASSESS A MODERATE TO SEVERE LESION. WHILE IVUS WAS PLACED, PROCEDURE COMPLICATED BY CARDIAC ARREST AND HYPOTENSION REQUIRING 50 MINUTES RESUSCITATION. PATIENT WAS TRANSFERRED TO CCU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423112 TVC INSIGHT CATHETER NIRS IVUS CORONARY IMAGING CENTER OGZ INFRAREDX INC. TVC-C195-22 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L NONE IDENTIFIED