BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIPISCAN CORONARY IMAGING CATHETER

    MDR report key: 1516711 · Received October 14, 2009

    Report

    Report Number
    3004722468-2009-00001
    Event Type
    Malfunction
    Date Received
    October 14, 2009
    Date of Event
    September 14, 2009
    Report Date
    October 14, 2009
    Manufacturer
    INFRAREDX INC.
    Product Code
    DQO
    PMA / PMN Number
    K072932
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM ARCHIVE DATA WAS FORWARDED TO INFRAREDX FOR REVIEW. NOTHING UNUSUAL WAS NOTED REGARDING THE SYSTEM PERFORMANCE DURING THE PROCEDURE. ANGIOGRAPHIC FILMS WERE FORWARDED ALONG TO INFRAREDX. NO UNUSUAL FINDINGS. THE ROOT CAUSE OF THIS COMPLAINT IS DETERMINED TO BE INCONCLUSIVE. A PLAN HAS BEEN PUT IN PLACE TO RE-TRAIN THE OPERATOR TO THE PROCEDURE FOR REMOVAL OF THE CATHETER FROM THE PT. THIS CUSTOMER COMPLAINT HAS BEEN CLOSED, NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    DURING PCI, PHYSICIAN WAS USING LIPISCAN CORONARY IMAGING SYSTEM AND CATHETER (MFG BY INFRAREDX) IN CONJUNCTION WITH A STANDARD GUIDEWIRE (NOT MANUFACTURED OR PROVIDED BY INFRAREDX). DURING REMOVAL OF THE LIPISCAN CORONARY CATHETER FROM THE CORONARY ARTERY OF PT FOLLOWING A SUCCESSFUL SCAN, THE LIPISCAN CATHETER AND GUIDEWIRE SNAGGED. THE CATHETER AND GUIDEWIRE WERE THEN REMOVED FROM PT TOGETHER. AFTER REMOVAL, THE LIPISCAN CATHETER WAS PULLED/SEPARATED FROM THE GUIDEWIRE . DAMAGE WAS NOTICED TO THE INFRAREDX LIPISCAN CORONARY CATHETER AT THE DISTAL TIP. THE LIPISCAN CATHETER SUSTAINED A SMALL SLICE TO THE SHEATH LENGTHWISE AND PROXIMAL TO THE RADIOPAQUE MARKER DISTAL TO THE FIBER OPTIC DISTAL POSITION. IT IS UNCLEAR WHEN THE SLICE OCCURRED. UPON DISCUSSIONS WITH THE SITE, IT IS SPECULATED THAT THE SLICE MAY HAVE OCCURRED DURING SEPARATION OF THE CATHETER FROM THE GUIDEWIRE OUTSIDE OF THE PT. A SUCCESSFUL SCAN WAS COMPLETED PRIOR TO THE REMOVAL OF THE CATHETER AND GUIDEWIRE. PER REMOVAL PROCEDURES, PRIOR TO REMOVAL OF THE CATHETER, THE OPERATOR IS INSTRUCTED TO TURN THE PBR KNOB TO THE LEFT (LOCKED POSITION). THE OPERATOR CANNOT RECALL WHETHER THIS STEP WAS EXECUTED. THE CATHETER WAS DISPOSED OFF BY THE SITE STAFF AND THUS NOT RETURNED TO INFRAREDX FOR FURTHER INVESTIGATION. THERE WAS NO PT INJURY REPORTED. A CLINICAL SPECIALIST (INFRAREDX EMPLOYEE) WAS NOT PRESENT DURING THE PROCEDURE, HOWEVER A DISCUSSION WITH THE PHYSICIAN WAS HELD TO CONFIRM THE FACTS OF THE INCIDENT. ARCHIVE DATA WAS FORWARDED TO INFRAREDX. F/U WITH THE SITE CONFIRMED THAT NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIPISCAN CORONARY IMAGING CATHETER NIR CORONARY IMAGING CATHETER DQO INFRAREDX INC. NIRC-MC5-02-3.2F 905142

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE NOTED.