BEUDAMED
    FDA Adverse Event Death Summary report: N

    EAGLE EYE PLATINUM DIGITAL IVUS CATHTER

    MDR report key: 2989046 · Received February 28, 2013

    Report

    Report Number
    2939520-2013-00010
    Event Type
    Death
    Date Received
    February 28, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    VOLCANO CORP
    Product Code
    OBJ
    PMA / PMN Number
    K092596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EAGLE EYE PLATINUM IVUS CATHETER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE DEVICE WAS VISUALLY EXAMINED UNDER A MICROSCOPE BY THE MANUFACTURER AND A KINK WAS OBSERVED IN THE PROXIMAL SHAFT AT APPROXIMATELY 58.5 CM FROM THE END OF THE DISTAL TIP. ALL OTHER ASPECTS OF THE CATHETER WERE INTACT. THERE WAS NO DAMAGE OBSERVED AT THE DISTAL OR PROXIMAL ENDS OF THE CATHETER. THERE WERE NO SHARP POINTS, JAGGED EDGES OR BURRS OBSERVED ON THE BODY OF THE CATHETER ITSELF. FURTHER FUNCTIONAL TESTING AND INSPECTION OF THE SCANNER FOUND FLUID INGRESS INTO THE PROXIMAL EDGE OF THE SCANNER AND PROXIMAL FILLET TRANSITION THUS CAUSING A SHORT. BASED ON THE PHYSICAL EXAMINATION OF THE IVUS CATHETER, THE OBSERVED DAMAGE IN THE SCANNER IS A RESULT OF AN OPENING BETWEEN THE SCANNER AND PROXIMAL FILLET WHICH ALLOWED FOR A FLUID PATH INTO THE ELECTRICAL CIRCUITRY RESULTING IN THE DEVICE FAILURE AND PROMPTING THE OBSERVED "CATHETER FAULT DETECTED" MESSAGE. THE MANUFACTURER WAS INITIATED A CONTINUOUS IMPROVEMENT PROGRAM TO INVESTIGATE THESE TYPES OF FAILURES. IN ADDITION THE MANUFACTURER'S REPRESENTATIVE WAS VERBALLY INFORMED OF THE SITUATION AND THAT IT WAS SUSPECTED THAT A SPIRAL DISSECTION FROM THE LEFT MAIN OCCURRED; HOWEVER, TO DATE, THE EXACT CAUSE OF DEATH OR ARTERIAL DISSECTION IS UNK. THE PROCEDURE WAS PERFORMED AS STAGED PROCEDURE AS THE PT RECENTLY HAD UNDERGONE A DIAGNOSTIC ANGIOGRAM AND WAS SCHEDULED FOR STENT PLACEMENT IN THE CIRCUMFLEX ARTERY. THE SITE INFORMED THE MANUFACTURER THAT A GUIDEWIRE HAD BEEN PLACED IN THE CIRCUMFLEX AND AN IVUS PULLBACK WAS SUCCESSFULLY PERFORMED, THE PHYSICIAN WAS SUSPECTED OF POTENTIAL LEFT MAIN DISEASE AND WAS DECIDING TO PERFORM THE INTERVENTION OR SEND FOR CORONARY ARTERY BYPASS GRAFT SURGERY (CABG) AT THE TIME THE PT BECAME UNSTABLE. AS STATED ABOVE, UPON MICROSCOPIC EXAMINATION THERE WERE NO SHARP POINTS, JAGGED EDGES OR BURRS OBSERVED ON THE BODY OF THE CATHETER ITSELF, WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. THE MANUFACTURER HAS REQUESTED THE ANGIOGRAM, IVUS IMAGES AND/OR CASES FILES ASSOCIATED WITH THIS CASE AND IT IS PENDING THESE FROM THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IVUS PROCEDURE, AN ERROR MESSAGE OF "CATHETER FAULT DETECTED" WAS EXPERIENCED. PER THE CUSTOMER, THE CATHETER WAS UNPLUGGED AND RE-PLUGGED WITH RECURRENCE OF THE SAME ERROR MESSAGE. THE SYSTEM WAS THE REBOOTED, MEANWHILE THE PT CODED AND PASSED BECAME HEMODYNAMICALLY UNSTABLE, CARDIAC ARREST ENSUED AND DESPITE RESUSCITATION EFFORTS, THE PT DIED IN THE CARDIAC CATHETERIZATION LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86803 EAGLE EYE PLATINUM DIGITAL IVUS CATHTER INTRAVASCULAR ULTRASOUND CATHETER OBJ VOLCANO CORP 85900P 127 50118

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death