BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIPISCAN CORONARY IMAGING CATHETER

    MDR report key: 2688891 · Received March 17, 2011

    Report

    Report Number
    3004722468-2011-00002
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    INFRAREDX INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANGIOGRAPHIC FILMS WERE FORWARDED TO INFRAREDX. NO ANGIOGRAPHIC IMAGES WERE CAPTURED SHOWING THE LIPISCAN IVUS CATHETER IN THE CORONARY ARTERY OR ANY DIFFICULTY REMOVING THE CATHETER OR DAMAGE TO THE GUIDE WIRE WERE SEEN AS DESCRIBED IN THE COMPLAINT SUMMARY. THE CATHETER IN QUESTION WAS RETURNED TO INFRAREDX FOR INVESTIGATION. UNFORTUNATELY, THE GUIDE WIRE WAS REMOVED FROM THE CATHETER AT THE SITE AND DISCARDED. THEREFORE, IT WAS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE GUIDE WIRE, IT COULD NOT BE DETERMINED FOR CERTAIN IF THE TEAR WAS CAUSED DURING THE PROCEDURE OR UPON REMOVAL OF THE GUIDE WIRE. A VERBAL REPORT FROM THE (B)(6) EMPLOYEE WHO REMOVED THE GUIDE WIRE STATED THAT THE TEAR WAS LIKELY CAUSED BY THE GUIDE WIRE AS SHE EXTRACTED IT FROM THE CATHETER MONORAIL. SHE ALSO STATED THAT THE SECTION OF THE GUIDE WIRE JUST PROXIMAL TO THE CATHETER MONORAIL WAS KINKED, THUS SHE HAD TO REMOVE THE WIRE BY PULLING THE DISTAL FLOPPY END OF THE WIRE BACK THROUGH THE MONORAIL WHICH IS OPPOSITE NORMAL LOADING/UNLOADING DIRECTION. INFRAREDX WILL OBTAIN THE SAME BRAND OF GUIDE WIRE USED IN THE PROCEDURE AND REPEAT THE SIMULATED-USE TESTING PERFORMED DURING INVESTIGATION.

    Description of Event or Problem · 1

    LIPISCAN IVUS CATHETER TEST WAS PERFORMED AND IVUS IMAGE APPEARED BEFORE INSERTION INTO THE VESSEL. A STANDARD 0.014 GUIDE WIRE NOT MANUFACTURED BY INFRAREDX WAS USED TO FACILITATE ENTRY OF THE LIPISCAN IVUS CATHETER AS CUSTOMARY. IN THE FIRST 20MM OF THE SCAN, THE GOOD SPECTRA LIGHTS APPEARED ALTHOUGH THERE WAS A LOT OF NON UNIFORM ROTATIONAL DISTORTION (NURD) IN THE IVUS IMAGE DUE TO THE TIGHTNESS OF THE LESION. AS THE GUIDE WIRE MAP STOPPED COLLECTING DATA DUE TO A DATA COLLECTION ERROR, THE PHYSICIAN PUSHED THE STOP BUTTON ON THE PBR AND PROCEEDED TO REMOVE THE CATHETER. AS THE PHYSICIAN ATTEMPTED TO REMOVE THE LIPISCAN IVUS CATHETER, HE COMMENTED THAT HE FELT SOME TIGHTNESS ON THE WIRE AND ELECTED TO REMOVE BOTH WIRE AND CATHETER TOGETHER. UPON REMOVAL, THE GUIDE WIRE WAS KINKED IN SEVERAL PLACES. THE PT COMPLAINED OF CHEST PAIN. A PICTURE OF THE HEART WAS TAKEN AND A DISSECTION OF THE ARTERY WAS DISCOVERED. AFTER MANY ATTEMPTS AND THE USE OF MULTIPLE WIRES, THE GUIDING CATHETER WAS REDIRECTED AND A GUIDE WIRE WAS SUCCESSFULLY MANIPULATED INTO THE TRUE LUMEN. NEXT, STENTS WERE PLACED IN THE VESSEL TO ADEQUATELY TREAT THE DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIPISCAN CORONARY IMAGING CATHETER LIPISCAN IVUS CORONARY IMAGING CATHETER DQO INFRAREDX INC. NIRC-MC7-70-3.2F 011301

    Patients

    Seq Age Sex Outcome Treatment
    1 17 DA Life Threatening