BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERRATA PRESSURE GUIDE WIRE

    MDR report key: 6065402 · Received October 28, 2016

    Report

    Report Number
    2939520-2016-00079
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 7, 2016
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K131288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. THE INSTRUCTIONS FOR USE (IFU) INDICATE UNDER ADVERSE EFFECTS THAT "AS WITH ALL CATHETERIZATION PROCEDURES, COMPLICATIONS MAY BE ENCOUNTERED WITH THE USE OF THE PRESSURE GUIDE." THE IFU ALSO WARNS, "DO NOT FLEX THE PROXIMAL (ELECTRICAL CONNECTOR) END OF THE PRESSURE GUIDE WIRE WHEN NOT INSERTED IN THE CONNECTOR. EXCESSIVE FLEXING CAN DAMAGE OR BREAK THE INTERNAL COMPONENTS. NEVER ADVANCE, TORQUE OR RETRACT A PRESSURE GUIDE WIRE WHICH MEETS SIGNIFICANT RESISTANCE. THE WIRE SHOULD NEVER BE FORCIBLY PUSHED INTO A VESSEL. ANY TIME THAT RESISTANCE IS ENCOUNTERED, THE WIRE SHOULD BE WITHDRAWN UNDER FLUOROSCOPIC GUIDANCE. IN SOME INSTANCES, THE WIRE MAY KINK AND MUST BE REMOVED."

    Description of Event or Problem · 1

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED DURING THE OPERATION CHECK OF THE SECOND WIRE PRIOR TO INSERTION IN THE ARTERY, THE WIRE COULD ZERO BUT THE PD CURVE WAS NOT DISPLAYED. THE WIRE, THE CONNECTOR CABLE AND THE PIMMETTE WERE RECONNECTED TO THE CONNECTOR CABLE, THE PIMMETTE AND THE SYSTEM, BUT THE PROBLEM WAS NOT SOLVED. ANOTHER SAME DEVICE WAS UTILIZED. THE EVENT OCCURRED PRIOR TO THE PROCEDURE. THE WIRE WAS NEVER INSERTED INTO THE PATIENT'S BODY. THERE WAS NO PATIENT INJURY. THIS MDR IS BEING SUBMITTED BECAUSE THE RETURNED DEVICE WAS RECEIVED WITH THE SENSOR BROKEN AND THE DISTAL PORTION WAS MISSING. VISUAL AND MICROSCOPIC INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE SENSOR WAS BROKEN AND THE DISTAL END OF THE SENSOR, INCLUDING THE MAJORITY OF THE DIAPHRAGM WAS MISSING. THE REMAINING PORTION OF THE SENSOR WAS RAISED. AN ELECTRICAL RESISTANCE TEST WAS PERFORMED TO FIND ANY FAILURES IN THE ELECTRICAL CIRCUIT OF THE DEVICE. THE TEST DISCOVERED UNSTABLE, WEAK CONNECTIONS BETWEEN ALL THREE CONDUCTIVE BANDS. THE WIRE FAILED THE SIGNAL TEST AND WAS NOT RECOGNIZED. THE PROBABLE CAUSE OF THE OBSERVED FAILURE WAS UNSTABLE, WEAK CONNECTIONS IN THE ELECTRICAL CIRCUIT OF THE DEVICE, LIKELY DUE TO THE BROKEN SENSOR. HOWEVER, WE WERE UNABLE TO CONCLUSIVELY DETERMINE WHEN OR HOW THE DAMAGE TO THE SENSOR OCCURRED. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THERE WERE NO NONCONFORMING MATERIAL REPORTS OR DEVIATIONS NOTED THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE MODE. THIS COMPLAINT WILL BE MONITORED AS PART OF COMPLAINT DATA ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715453 VERRATA PRESSURE GUIDE WIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORPORATION 10185 0243 50056869

    Patients

    Seq Age Sex Outcome Treatment
    1