BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVC INSIGHT CATHETER

    MDR report key: 4431960 · Received January 16, 2015

    Report

    Report Number
    3004722468-2014-00003
    Event Type
    Injury
    Date Received
    January 16, 2015
    Date of Event
    December 16, 2014
    Report Date
    January 15, 2015
    Manufacturer
    INFRAREDX INC.
    Product Code
    OGZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER WAS RETURNED AND WAS INSPECTED BOTH VISUALLY AND FUNCTIONALLY. THERE WERE NO VISUAL EVIDENCE OF FAILURE OR MIS-USE. THE CATHETER HAD NO VISUAL SIGNS OF KINKING OR BREAKAGE. CATHETER WAS SHOWN TO BE FULLY FUNCTIONALLY, TACKING WELL THROUGH A SIMULATED ARCH AND PRODUCING BOTH AN IVUS IMAGE AS WELL AS NIR DATA. NO PROBLEM FOUND.

    Description of Event or Problem · 1

    PERCUTANEOUS CORONARY INTERVENTION: SUCCESSFUL DEPLOYMENT OF 3.5 X 18MM RESOLUTE DES TO MID-LCX, 75% TO 0% WITH EXCELLENT ANGIOGRAPHIC RESULT AND TIMI 3 FLOW. DISSECTION WAS NOTED PROXIMAL TO THE MID-STENT, SUCCESSFULLY COVERED WITH STENT IN PROXIMAL LCX. SUCCESSFUL DEPLOYMENT OF 3.5 X 18MM RESOLUTE DES TO PROXIMAL LCX, 75% TO 0% WITH EXCELLENT ANGIOGRAPHIC RESULTS AND TIMI 3 FLOW. PATIENT UNDERWENT A COMPLEX INTERVENTION AND HAD CHEST PAIN DURING THE PROCEDURE. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40955 TVC INSIGHT CATHETER NIRS IVUS CORONARY IMAGING CATHETER OGZ INFRAREDX INC. TVC-C195-22 D01234

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R