BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEWIRE PRESTIGE PRESSURE GUIDE WIRE

    MDR report key: 2241686 · Received August 19, 2011

    Report

    Report Number
    2939520-2011-00055
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 28, 2011
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DXO
    PMA / PMN Number
    K100930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MFG DOCUMENTATION FOR THE RETURNED DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MFG RELEASE CRITERIA. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. THE DEVICE WAS RETURNED TO THE MFR IN DAMAGED CONDITION. THE HYPOTUBE WAS KINKED AT MULTIPLE LOCATIONS; AND THE DISTAL PART OF THE PRESSURE SENSOR WAS MISSING. FUNCTIONAL TEST WAS PERFORMED AND THE WIRE WAS NOT RECOGNIZED AND COULD NOT ZERO. THE "ATTACH WIRE TO CONNECTOR" MESSAGE WAS DISPLAYED INDICATING A SIGNAL FAILURE WHICH IS LIKELY DUE TO THE MISSING DISTAL PART OF THE PRESSURE SENSOR. (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 OR DISTALLY. IN THE EVENT THAT A PORTION OF THE SENSOR WERE 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 INFARCTION OF THE IMPACTED VASCULAR BED. HOWEVER, NONE OF THESE POSSIBLE EVENTS WERE REPORTED. NO ADVERSE EVENTS WERE REPORTED BY THE USER. THE IFU PRECAUTION STATEMENTS INDICATE "DO NOT USE PRODUCT, WHICH HAS BEEN DAMAGED IN ANY WAY; WHICH MAY RESULT IN VESSEL DAMAGE, INACCURATE PRESSURE MEASUREMENTS AND/OR POOR TORQUE RESPONSE." THIS EVENT IS BEING REPORTED AS IT IS NOT POSSIBLE TO DETERMINE WHEN THE PRESSURE SENSOR WAS SEPARATED. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT PRIOR TO INSERTION INTO THE PT, THE PRESSURE GUIDE WIRE WAS CONNECTED INTO THE PIM AND AN ERROR MESSAGE WAS DISPLAYED ON THE SCREEN. THE PRESSURE GUIDE WIRE WAS UNPLUGGED AND PLUGGED BACK INTO THE PIM AND IT WAS NEVER RECOGNIZED. A SECOND PRESSURE GUIDE WIRE WAS SUCCESSFULLY USED. CONTRARY TO THE ORIGINAL REPORT FROM THE CUSTOMER, ADD'L INFO REPORTED THAT THE PRESSURE GUIDE WIRE HAD INDEED BEEN INSERTED IN THE PT'S BODY. AFTER IT WAS INSERTED, THE PRESSURE GUIDE WIRE WOULD NOT RESPOND. IT WAS REPORTED THAT THE USER SHAPED THE WIRE WITH A NEEDLE INTRODUCER. THERE WAS NO REPORT OF PT INJURY. THE DEVICE WAS RETURNED TO THE MFR FOR EVAL. DURING EXAMINATION OF THE DEVICE IT WAS OBSERVED THAT THE DISTAL PART OF THE PRESSURE SENSOR WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEWIRE PRESTIGE PRESSURE GUIDE WIRE TRANSDUCER, PRESSURE, CATHETER TIP DXO VOLCANO CORPORATION 8185 114 01191

    Patients

    Seq Age Sex Outcome Treatment
    1