BEUDAMED
    FDA Adverse Event Summary report: N

    TVC INSIGHT CATHETER

    MDR report key: 3503544 · Received November 19, 2013

    Report

    Report Number
    3004722468-2013-00004
    Date Received
    November 19, 2013
    Date of Event
    October 16, 2013
    Report Date
    November 16, 2013
    Manufacturer
    INFRAREDX INC.
    Product Code
    OGZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER WAS RETURNED TO MANUFACTURER FOR INVESTIGATION. UPON RECEIPT, CATHETER WAS INSPECTED FOR ANY VISUAL OR MANUFACTURING DEFECTS. NONE FOUND. CATHETER WAS THEN TESTED ON A TEST BED AND FOUND TO BE FULLY FUNCTIONAL, PRODUCING FUNCTIONAL CHEMOGRAMS AND IVUS INFO.

    Description of Event or Problem · 1

    PT PRESENTED FOR PCI. DURING PROCEDURE, INFRAREDX CATHETER WAS PREPPED ACCORDING TO IFU. IT WAS INSERTED INTO THE OM2 AND AT THAT TIME THE FELLOW NOTICED THE PT HAD NO PRESSURE. DOCTOR TIGHTENED THE TOUHY AND STILL NO PRESSURE ON THE MONITOR. HE DECIDED TO PROCEED WITH PULLBACK. THE RESULTS WERE OUTLIERS, INDICATIVE OF AIR IN EITHER THE CATHETER OR VESSEL. THE PT BEGAN CRASHING AT THIS TIME AND THE CATHETER WAS REMOVED. AFTER INTUBATION AND CPR, DOCTOR TOOK A QUICK ANGIOGRAM AND THE VESSEL WAS CLOSED. DOCTOR INTERVENED, USING AN EXPORT CATHETER AND MEDICATION. PT STABILIZED. DOCTOR CONFIRMED VESSEL WAS OPEN. DOCTOR BELIEVES ROOT CAUSE TO BE AN AIR EMBOLUS AND NOT CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598042 TVC INSIGHT CATHETER NIR-IVUS CORONARY IMAGING CATHETER OGZ INFRAREDX INC. TVC-C195-20 304242-A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening| R