BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVC INSIGHT CATHETER

    MDR report key: 3412997 · Received October 10, 2013

    Report

    Report Number
    3004722468-2013-00002
    Event Type
    Injury
    Date Received
    October 10, 2013
    Date of Event
    March 21, 2013
    Report Date
    October 10, 2013
    Manufacturer
    INFRAREDX INC.
    Product Code
    OGZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED VENTRICULAR FIBRILLATION DURING CATHETER DWELL TIME. VIA RIGHT FEMORAL ARTERY WITH SELDINGER TECHNIQUE AND ONE WALL STICK, THE RIGHT FEMORAL ARTERY WAS ENTERED AND A 6 FRENCH SHEATH WAS PLACED. A NUMBER 4 LEFT SELECTIVE CORONARY CATHETER WAS ADVANCED TO THE ASCENDING AORTA. THE LEFT CORONARY CATHETER SELECTIVELY CANNULATED. NUMEROUS INJECTIONS PERFORMED WITH DIGITAL FILMING. THIS CATHETER REPLACED BY NUMBER 4 RIGHT SELECTIVE CORONARY CATHETER. IT WAS ADVANCED TO THE ASCENDING AORTA, THE RIGHT CORONARY ARTERY SELECTIVELY CANNULATED. NUMEROUS INJECTIONS PERFORMED WITH JUST DIGITAL FILMING. REPLACED WITH PIGTAIL CATHETER. PRESSURES WERE RECORDED AND ALL CATHETERS WERE REMOVED. MOVED ON TO IMAGING AS WELL AS FRACTIONAL FLOW WIRE. DURING IMAGING CATHETER MAY HAVE OCCLUDED FLOW DUE TO STENOSIS. VENTRICULAR TACHYCARDIA FIBRILLATION DEVELOPED REQUIRING CARDIOVERSION PROMPTLY BACK TO BASELINE. PHYSICIAN REPORTED EVENT WAS DUE TO ISCHEMIA FROM LONG DWELL TIME - WOULD HAVE OCCURRED WITH ANY IVUS CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518193 TVC INSIGHT CATHETER NIR/IVUS CORONARY IMAGING CATHETER OGZ INFRAREDX INC. NIRS-MC7-7-3.2F NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R