BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEWIRE PRESTIGE PRESSURE GUIDE WIRE

    MDR report key: 3190682 · Received June 24, 2013

    Report

    Report Number
    2939520-2013-00023
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 3, 2013
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K100930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND INVESTIGATED ACCORDING TO VOLCANO POLICY. DURING EXAMINATION OF THE RETURNED PRESSURE GUIDEWIRE, IT WAS OBSERVED THAT THE HYPOTUBE WAS KINKED IN MULTIPLE LOCATIONS; A STRETCHED TIP COIL DISTAL TO THE SENSOR WAS OBSERVED. THE DISTAL PART OF THE PRESSURE SENSOR WAS MISSING FROM THE DEVICE AND THE TIP APPEARED TO BE SHAPED. THE SIGNAL TEST WAS PERFORMED AND THE DEVICE FAILED BY PRODUCING "ATTACH WIRE TO CONNECTOR" MESSAGE DUE TO THE MISSING PRESSURE SENSOR. THE REPORTED ERROR CODE OF "FAILED COMMUNICATION WITH THE PIM" WAS NOT DUPLICATED BUT CONFIRMED THAT THE DEVICE HAD SIGNAL ISSUES. THE PRESSURE SENSOR IS FABRICATED FROM (B)(4) AND IS NOT READILY SEEN ON X-RAY EQUIPMENT COMMONLY USED IN THE CARDIAC CATH; IT MAY OR MAY NOT APPEAR ON THE CINE OR FLUOROSCOPY DEPENDING ON THE SIZE OF THE VESSEL. IN THE EVENT THAT PORTION OF THE SENSOR WAS LEFT INSIDE THE CORONARY ARTERY, THE FOLLOWING POSSIBLE EVENTS COULD HAVE TAKEN PLACE: VESSEL SPASM, VESSEL CLOSURE DUE TO THROMBOSIS, ISCHEMIA ON ECG AND/OR CHEST PAIN, AND/OR MYOCARDIAL INFRACTION OF THE IMPACTED VASCULAR BED. HOWEVER, NONE OF THESE POSSIBLE EVENTS WERE REPORTED. THERE WAS NO PT INJURY REPORTED. THE PT WAS RELEASED ACCORDING TO THE ORIGINAL TREATMENT PLAN AND IS ON MEDICAL THERAPY BUT NO PCI. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THIS EVENT IS BEING REPORTED AS IT IS NOT POSSIBLE TO DETERMINE WHEN THE PRESSURE SENSOR BECAME MISSING/BROKEN. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO DO AN FFR OF AN LAD LESION (A STRAIGHTFORWARD PROXIMAL CIRCUMFLEX LESION THAT WAS INTERMEDIATE IN NATURE ABOUT 50%). THE WIRE WAS ZEROED BUT WHEN PLACED INTO THE BODY, AN ERROR CODE "FAILED COMMUNICATION WITH THE PIM" WAS RECEIVED. MULTIPLE ATTEMPTS WERE MADE TO REZERO THE WIRE BUT THE SAME ERROR MESSAGE REAPPEARED. A SECOND WIRE WAS USED BUT THE SAME ERROR MESSAGE OCCURRED. THEY DECIDED TO ABORT THE FFR PROCEDURE AND PERFORM AN IVUS INSTEAD. THERE WAS NO PT INJURY REPORTED. THE PT WAS RELEASED ACCORDING TO THE ORIGINAL TREATMENT PLAN AND IS ON MEDICAL THERAPY BUT NO PCI. THE PRESSURE GUIDEWIRE WAS RECEIVED BY THE MANUFACTURER AND DURING THE EVALUATION, IT WAS OBSERVED THAT THE DISTAL PART OF THE PRESSURE SENSOR WAS MISSING FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286721 PRIMEWIRE PRESTIGE PRESSURE GUIDE WIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORPORATION 8185 114 01157

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDTRONIC LAUNCHER 6 FRENCH EBU 3.5| GUIDE CATHETER