BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEWIRE PRESTIGE PLUS

    MDR report key: 3970700 · Received June 2, 2014

    Report

    Report Number
    2939520-2014-00041
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    October 22, 2013
    Report Date
    May 8, 2014
    Manufacturer
    VOLCANO S.R.L.
    Product Code
    DQX
    PMA / PMN Number
    K111395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MFG DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUAL AND MFG RELEASE CRITERIA. TO DATE, THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. VISUAL AND MICROSCOPIC INSPECTIONS AND FUNCTIONAL TESTINGS WERE PERFORMED ON THE RETURNED DEVICE. THE PRESSURE SENSOR WAS BROKEN AND IS MISSING THE DISTAL PART. THE DISTAL TIP APPEARED TO BE CURVED AND WAVY. THE TORQUE DEVICE WAS NOT RETURNED. AN ELECTRICAL RESISTANCE TEST WAS PERFORMED TO FIND ANY OPEN AND/OR SORTS IN THE ELECTRICAL CIRCUIT OF THE DEVICE AND THE TEST REVEALED THAT ALL THREE CONDUCTIVE BANDS WERE BROKEN. WHEN FUNCTIONALLY TESTED, AN "ATTACH WIRE TO CONNECTOR" MESSAGE WAS DISPLAYED. THE WIRE WAS NOT RECOGNIZED AND FAILED TO PRODUCE A PRESSURE SIGNAL. A REGULAR "DRIFT" TEST TO VERIFY ANY SIGNAL DRIFT ISSUES WITH THE DEVICE WHICH MAY RESULT IN POOR NORMALIZATION WAS NOT POSSIBLE. THE REPORTED NORMALIZATION ISSUE COULD NOT BE DUPLICATED HOWEVER, A SIGNAL FAILURE DID OCCUR 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 THE SENSOR DAMAGE 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 CORP SCIENTIFIC AFFAIRS DEPARTMENT. THE RESULTS OF THE ASSESSMENT ARE SUMMARIZED BELOW: NO PT INJURY WAS REPORTED. NO INTERVENTION WAS REQUIRED TO MITIGATE PT HARM. ALTHOUGH THERE WAS NO EFFECT ON THE PT IN THIS CASE, BECAUSE THE DEVICE WAS TESTED OUTSIDE THE BODY PRIOR TO INSERTION, AS RECOMMENDED IN THE INSTRUCTIONS FOR USE (IFU), THIS FAILURE MODE COULD POTENTIALLY CAUSE PT HARM IF IT WERE TO REOCCUR WHILE IN SITU. IF THE SENSOR WERE TO DETACH WHILE THE CATHETER WAS IN SITU, THEN THE SENSOR COULD MIGRATE AND EMBOLIZE, POTENTIALLY CAUSING SEVERE 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 INFO WILL BE PROVIDED SHOULD IT BECOME AVAILABLE. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS FAILURE MODE VIA OUR STANDARD 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 DURING THE PROCEDURE, PRIOR TO INSERTION, THE WIRE WAS PLUGGED INTO THE SYS BUT FAILED TO NORMALIZE. ANOTHER WIRE WAS USED AND WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER ISSUES. AS PER ADDITIONAL INFO PROVIDED, NO VISUAL DAMAGE WAS OBSERVED ON THE DEVICE DURING PREPARATION. THE DEVICE WAS NOT BROKEN INTO 2 PIECES AND ALL PORTIONS OF THE WIRE APPEARED TO BE ACCOUNTED FOR. THE DEVICE NEVER CROSSED THE LESION AND NO RESISTANCE WAS FELT AT ANY TIME DURING THE PROCEDURE. THE PRESSURE GUIDEWIRE WAS RECEIVED BY THE MFR AND DURING EVALUATION IT WAS OBSERVED THAT THE REPORTED SERIAL NUMBER OF THE DEVICE WAS DIFFERENT FROM WHAT WAS RECEIVED. DEVICE EVALUATION WAS PERFORMED ON THE RECEIVED DEVICE AND IT WAS OBSERVED THAT THE DISTAL PORTION ON OF THE PRESSURE SENSOR WAS MISSING FROM THE DEVICE. NO PT INJURY OR ADVERSE EVENTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320947 PRIMEWIRE PRESTIGE PLUS WIRE, GUIDE CATHETER DQX VOLCANO S.R.L. 9185 0110 50000149

    Patients

    Seq Age Sex Outcome Treatment
    1