BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX

    MDR report key: 1579907 · Received January 14, 2010

    Report

    Report Number
    2939520-2010-00004
    Event Type
    Other
    Date Received
    January 14, 2010
    Date of Event
    August 29, 2009
    Report Date
    October 16, 2009
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DXO
    PMA / PMN Number
    K070487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS VISUALLY INSPECTED UPON RETURN. THE FOLLOWING DAMAGE WAS NOTED: SIGNIFICANT STRETCHES, KINKS AND BENDS, GREEN DISCOLORATION ON THE CABLE CONNECTOR, A BROKEN AND MISSING SENSOR, AND A MISSING DISTAL TIP DOME (APPROXIMATELY 0.5MM X 0.5MM). THE COMPLAINT OF "DEVICE COULD NOT ZERO" IS LIKELY DUE TO LIQUID INGRESS DURING THE PROCEDURE RESULTING IN THE OBSERVED GREEN DISCOLORATION OF THE CABLE CONNECTOR. IT IS HIGHLY UNLIKELY THE SENSOR BROKE OFF WHILE INSIDE THE PATIENT. IF THE SENSOR HAD BROKEN OFF INSIDE THE PATIENT, THE SYSTEM WOULD DISPLAY AN ERROR CODE "ATTACH WIRE TO CONNECTOR. THE SENSOR WAS STILL PRESENT AFTER PATIENT USE SINCE THE DEVICE PRODUCED A COULD NOT ZERO ERROR PRIOR TO REINSERTION INTO THE PATIENT. IT IS ALSO HIGHLY UNLIKELY THE DOME WAS LOST INSIDE THE PATIENT. A MISSING DOME WOULD LEAD TO RESISTANCE POOR STEERABILITY, AND ELEVATED ENZYME LEVELS DURING THE PROCEDURE. THE USER DID NOT REPORT ANY RESISTANCE OR STEERABILITY ISSUES AND DID NOT REPORT AN ADVERSE EVENT SO ENZYME LEVELS WERE NOT ELEVATED. UPON NOTIFICATION OF THE MISSING SENSOR AND DISTAL TIP, AND INQUIRY INTO THE PATIENT CONDITION, THE MANUFACTURER WAS INFORMED THAT THE PATIENT EXPERIENCED NO ADVERSE EVENTS AND IS DOING FINE. THE MOST LIKELY SCENARIO IS THAT THE SENSOR AND DOME WERE DAMAGED AFTER THAT DEVICE WAS FIRST USED AND REMOVED FROM THE PATIENT, BUT PRIOR TO THE SECOND USE EITHER CAUSED BY HANDLING PRIOR TO THE PROCESS OF ZEROING THE WIRE OR DURING THE RETURN SHIPMENT OF THE DEVICE FOR EVALUATION. THERE WAS NO MALFUNCTION OF THIS DEVICE. MANAGEMENT REVIEW OF 01/14/2010 DETERMINED THIS CASE SHOULD BE REPORTED FOR NOTIFICATION PURPOSES ONLY.

    Description of Event or Problem · 1

    THE SMARTWIRE FUNCTIONED AS INTENDED DURING THE FIRST USE MEASURING FOR PRE-IVUS, BUT PRIOR TO THE SECOND USE FOR POST-IVUS, WAS UNABLE TO ZERO DURING THE OPERATION CHECK PRIOR TO INSERTION INTO THE PATIENT. SMARTWIRE USE WAS DISCONTINUED AT THIS POINT. UPON MANUFACTURER'S RECEIPT OF THE DEVICE FOR INVESTIGATION, IT WAS OBSERVED THAT THE SENSOR WAS FRACTURED AND PARTIALLY MISSING AND THE DOME WAS FOUND MISSING FROM THE DISTAL TIP. THE DEVICE WAS DECONTAMINATED PRIOR TO EVALUATION. THE PATIENT IS CURRENTLY DOING WELL AND HAS NOT EXPERIENCED ANY ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX TRANSDUCER, PRESSURE, CATHETER TIP DXO VOLCANO CORPORATION 6600 040 02760

    Patients

    Seq Age Sex Outcome Treatment
    1