BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVC INSIGHT CATHETER

    MDR report key: 2848418 · Received November 21, 2012

    Report

    Report Number
    3004722468-2012-00001
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    September 13, 2012
    Report Date
    November 21, 2012
    Manufacturer
    INFRAREDX INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    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 WAS MOST LIKELY DUE TO THE TORTUOUSITY OF THE VESSEL AND NOT A SPECIFIC FEATURE OF/OR DEFECT/MALFUNCTION OF THE TVC INSIGHT CATHETER. PHYSICIAN STATED THAT IT IS UNCLEAR WHETHER THE TVC INSIGHT CATHETER OR THE GUIDE WIRE LED TO THE DISSECTION. THE VESSEL WAS EXTREMELY TIGHT.

    Description of Event or Problem · 1

    (B)(6) WOMAN, PRESENTED TO HOSPITAL WITH CHEST PAIN AND INCREASING EXERTIONAL DYSPNEA. HISTORY OF CORONARY DISEASE WITH STENT PREVIOUSLY PLACED IN HER LAD. THE UNDERWENT CARDIAC CATHETERIZATION AND THIS REVEALED SIGNIFICANT LEFT MAIN STENOSIS. SHE ALSO HAD IN-STENT STENOSIS IN THE LAD STENT AND A LESION JUST DISTAL TO THE DISTAL ASPECT OF THE STENT. DURING THE PROCEDURE, INTRAVASCULAR ULTRASOUND WAS BEING PERFORMED USING THE TVC IMAGING SYSTEM AND TEMPORALLY RELATED TO THIS, SHE HAD ACUTE THROMBOSIS OF THE LEFT ANTERIOR DESCENDING. IT WAS QUICKLY RE-OPENED USING ANGIOPLASTY AND STENTING. SEVERE STENOSIS REMAINED IN VESSEL. PT IS WITHOUT ONGOING ISCHEMIA. PT SENT FOR EMERGENT BYPASS SURGERY. SURGERY SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TVC INSIGHT CATHETER NIR/IVUS CORONARY IMAGING CATHETER DQO INFRAREDX INC. NIRC-MC7-70-3.2F 207256

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R