BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEWIRE PRESTIGE PLUS

    MDR report key: 3905008 · Received May 27, 2014

    Report

    Report Number
    2939520-2014-00042
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    February 18, 2014
    Report Date
    May 9, 2014
    Manufacturer
    VOLCANO S.R.L.
    Product Code
    DQX
    PMA / PMN Number
    K111395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. TO DATE, THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. VISUAL AND MICROSCOPIC INSPECTIONS AND FUNCTIONAL TESTS WERE PERFORMED ON THE RETURNED DEVICE. IT WAS OBSERVED THAT THE WIRE WAS KINKED AT ABOUT 7.5 CM FROM THE PROXIMAL END. OTHER MINOR KINKS WERE OBSERVED ON THE DEVICE. THE PRESSURE SENSOR WAS MISSING WITH A STRETCHED COIL. THE DISTAL TIP APPEARED TO BE SHAPED AND WAVY. THE TORQUE DEVICE WAS NOT RETURNED. AN ELECTRICAL RESISTANCE TEST WAS PERFORMED TO FIND ANY OPEN AND/OR SHORTS IN THE ELECTRICAL CIRCUIT OF THE DEVICE AND THE TEST REVEALED THAT ALL THREE CONDUCTIVE BANDS WERE BROKEN. WHEN FUNCTIONALITY TESTED, AN "ATTACH WIRE TO CONNECTOR" MESSAGE WAS DISPLAYED. THE WIRE WAS NOT RECOGNIZED AND FAILED TO PRODUCE A PRESSURE SIGNAL. THE REPORTED FAILURE WAS DUPLICATED AND THE COMPLAINT WAS CONFIRMED. (B)(4). THE MOST LIKELY CAUSE OF THE OBSERVED SIGNAL FAILURE WAS THE SENSOR DAMAGE OBSERVED ON THE RETURNED DEVICE. IT IS POSSIBLE TO CAUSE DAMAGE TO THE SENSOR AND THEREFORE A SIGNAL MALFUNCTION AS A RESULT, IF THE DEVICE IS IMPACTED,, MANIPULATED OR IF EXCESSIVE FORCE IS APPLIED. EXCESSIVE FLEXING CAN BREAK OR DAMAGE THE INTERNAL COMPONENTS WHICH COULD LIKELY RESULT TO SIGNAL FAILURE AND THEREFORE, NO SIGNAL CAN BE OBTAINED. A CLINICAL ASSESSMENT WAS CONDUCTED BY THE VOLCANO SCIENTIFIC AFFAIRS DEPARTMENT. THE RESULTS OF THE ASSESSMENT ARE SUMMARIZED BELOW: NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE WIRE AND CATHETER. ONE NOTED CLINICAL IMPLICATION WAS LOSS OF GUIDEWIRE POSITIONING WHICH RESULTED IN A DELAY IN THE CASE. A DELAY IN THE CASE MAY BE ASSOCIATED WITH ADDITIONAL RADIATION EXPOSURE AND CONTRAST VOLUME; HOWEVER, THE ADDITIONAL RADIATION EXPOSURE AND CONTRAST VOLUME RECEIVED IS TYPICALLY INSIGNIFICANT OVER THE LENGTH OF THE ENTIRE CASE. REPEATED CORONARY INTRODUCTION AND MANIPULATION POTENTIALLY INCREASES THE RISK OF ARRHYTHMIA (NOT THE CASE FOR PERIPHERAL INTERVENTIONS), VASOSPASM AND INTIMAL DAMAGE. CORONARY ARTERY VASOSPASM AND INTIMAL DAMAGE. CORONARY ARTERY VASOSPASM AND INTIMAL DISRUPTION MAY RESULT IN MYOCARDIAL ISCHEMIA AND/OR INJURY, SO THE CONSEQUENCES HAVE THE POTENTIAL TO BE MORE SIGNIFICANT AS COMPARED TO THOSE ENCOUNTERED IN PERIPHERAL ARTERIES. A BROKEN OR MISSING SENSOR HAS THE POTENTIAL TO CAUSE PATIENT HARM. IF THE SENSOR DETACHED WHILE THE CATHETER WAS IN SITU, THEN THE SENSOR COULD MIGRATE AND EMBOLIZE, POTENTIALLY CAUSING SEVER ADVERSE EVENTS. WE HAVE BEEN UNABLE TO CONCLUSIVELY DETERMINE WHEN THE SENSOR DAMAGE OCCURRED, OR THE CAUSE OF THE DAMAGE, THIS REPORT IS BEING FILED AS A PRECAUTIONARY MEASURE, AND ANY ADDITIONAL INFORMATION WILL BE PROVIDED SHOULD IT BECOME AVAILABLE. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS FAILURE MODE VIA OUR STANDARD COMPLAINT REVIEW PROCESS AND DATA TRENDING ACTIVITIES. NO FURTHER ACTION IS REQUIRED OR ANTICIPATED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WIRE WAS ZEROED AND NORMALIZED WITHOUT ANY ISSUES. HOWEVER, WHEN IT WAS ADVANCED DOWN THE ARTERY, THE PRESSURE SIGNAL WAS LOST AND AN "ATTACH WIRE TO CONNECTOR" MESSAGE WAS DISPLAYED. THE WIRE WAS DISCONNECTED AND RECONNECTED TO THE SYSTEM BUT THE SAME MESSAGE WAS RECEIVED. ANOTHER WIRE WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PRESSURE GUIDEWIRE WAS RECEIVED BY THE MANUFACTURER AND DURING EVALUATION, IT WAS OBSERVED THAT THE PRESSURE SENSOR WAS MISSING FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312091 PRIMEWIRE PRESTIGE PLUS WIRE, GUIDE, CATHETER DQX VOLCANO S.R.L. 9185 0110 50004381

    Patients

    Seq Age Sex Outcome Treatment
    1