BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVC INSIGHT CATHETER

    MDR report key: 3239943 · Received July 17, 2013

    Report

    Report Number
    3004722468-2013-00001
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 15, 2013
    Manufacturer
    INFRAREDX, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS FROM THE INFRAREDX INVESTIGATION OF THE ANGIOGRAPHIC FILMS AS WELL AS DISCUSSIONS WITH THE ATTENDING PHYSICIAN SUGGEST THAT THE ROOT CAUSE OF THIS EVENT MOST MORE LIKELY RELATED TO THE FIRST INFLATABLE DEVICE. DURING THIS FIRST INFLATION, THE WIRE WAS RETRACTED SLIGHTLY CAUSING THE TIP OF THE WIRE TO RESIDE IN THE TIGHT BEND OF AN ARTERY THAT EXPERIENCES A LARGER DEGREE OF CONTRACTION DURING EACH CARDIAC CYCLE.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD MAN, PRESENTED TO HOSPITAL WITH CHEST PAIN AND UNDERWENT CARDIAC CATHETERIZATION FOR A LESION LOCATED IN THE PROXIMAL RAMUS INTERMEDIUS. DURING THE PROCEDURE, INTRAVASCULAR ULTRASOUND WAS PERFORMED USING THE TVC IMAGING SYSTEM. POST REMOVAL OF TVC SYSTEM, AN INFLATABLE DEVICE WAS USED ON THE LESION. UPON REMOVAL OF THE INFLATABLE DEVICE, IT WAS DETERMINED THAT THE PT HAD A DISSECTION IN THE DISTAL RAMUS INTERMEDIUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331197 TVC INSIGHT CATHETER NIR/IVUS CORONARY IMAGING SYSTEM DQO INFRAREDX, INC. NIRS-MC7-7--3.2F 304234

    Patients

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