BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEWIRE PRESTIGE PRESSURE GUIDE WIRE

    MDR report key: 2211661 · Received August 5, 2011

    Report

    Report Number
    2939520-2011-00054
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    May 27, 2011
    Report Date
    July 22, 2011
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K100930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE. THE DEVICE WAS RETURNED FOR EVALUATION AND WAS TESTED FOR ITS FUNCTIONALITY. DURING SIGNAL TEST THE DEVICE FAILED TO ZERO AND PRODUCED AN ERROR CODE 104. THIS TYPE OF ERROR WAS THE RESULT OF AN EEPROM IN THE WIRE CONNECTOR THAT HAD BEEN ERASED. MICROSCOPIC EXAMINATION OF THE DEVICE REVEALED CONTAMINATION ON THE CONNECTOR PINS. THE CONTAMINATION OBSERVED ON THE CONNECTOR, WHICH WAS CONSISTENT WITH THE CHEMICALS USED IN THE FIELD CAN CONTRIBUTE TO THE EEPROM GETTING INADVERTENTLY ERASED. THE DRIFT TEST WAS NOT PERFORMED BECAUSE THE DEVICE FAILED TO ZERO. DURING VISUAL INSPECTION A KINK WAS OBSERVED AT ABOUT 7.5 CM FROM THE PROXIMAL END AND THE TIP WAS SHAPED. FURTHER MICROSCOPIC EXAMINATION REVEALED THAT THE SOLDERED DOME WAS CORRODED AWAY FROM THE TIP OF THE DEVICE AND YELLOWISH DEBRIS WAS NOTICED ON THE RADIOPAQUE COIL, SENSOR AND ITS HOUSING. THE TIP DOME DAMAGE IS NOT RELATED TO THE REPORTED COMPLAINT; THE TIP DOME HAS NO ELECTRICAL FUNCTIONALITY AND DOES NOT AFFECT THE SIGNAL. THE DOME IS INTENDED TO ENHANCE SMOOTH TRACKING AND REDUCED RESISTANCE DURING THE ADVANCING OF THE WIRE. A MISSING DOME COULD CONTRIBUTE TO DECREASED WIRE HANDLING PERFORMANCE. THERE WAS NO REPORT OF ANY RESISTANCE OR DECREASED OF WIRE HANDLING PERFORMANCE ON THIS CASE. IT IS LIKELY THAT THE DEVICE'S EXPOSURE TO CHEMICALS, BLOOD, AND ENVIRONMENTAL MOISTURE DURING PREPARATION/USE IN THE FIELD AND/OR HANDLING BEFORE IT WAS RETURNED TO THE MANUFACTURER COULD HAVE WEAKENED THE BOND BETWEEN THE DEVICE TIP AND THE DOME. THE SHAPING OF THE TIP COULD HAVE ALSO CONTRIBUTED TOWARDS THE WEAKENED STRENGTH. THIS EVENT IS BEING REPORTED BECAUSE THE MANUFACTURER COULD NOT DETERMINE AT THIS TIME WHEN THE DOME SEPARATED FROM THE DEVICE. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRESSURE GUIDE WIRE WAS USED DURING FFR MEASUREMENTS AND A CHANGE IN THE PRESSURE WAVES MEASUREMENTS WAS OBSERVED. A NEW PRESSURE GUIDEWIRE WAS USED AND COMPLETED THE PROCEDURE. NO PT INJURY OCCURRED AND IT WAS REPORTED THAT THE PT WAS RELEASED ACCORDING TO THE ORIGINAL TREATMENT PLAN. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING EXAMINATION IT WAS OBSERVED THAT THE SOLDERED DOME WAS CORRODED AWAY FROM THE TIP OF THE PRESSURE GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEWIRE PRESTIGE PRESSURE GUIDE WIRE TRANSDUCER, PRESSURE, CATHETER TIP DQX VOLCANO CORPORATION 8185 114 01465

    Patients

    Seq Age Sex Outcome Treatment
    1