BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERRATA PRESSURE GUIDE WIRE

    MDR report key: 6049014 · Received October 21, 2016

    Report

    Report Number
    2939520-2016-00076
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    August 30, 2016
    Report Date
    September 1, 2016
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K131288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 ANY TIME THAT RESISTANCE IS ENCOUNTERED, THE WIRE SHOULD BE WITHDRAWN UNDER FLUOROSCOPIC GUIDANCE.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 INVESTIGATED IN ACCORDANCE WITH THE MANUFACTURER'S POLICY. IT WAS REPORTED THAT DURING A CORONARY DIAGNOSTIC PROCEDURE THE YELLOW CURVE DID NOT APPEAR. THE WIRE WOULD NOT ZERO NOR NORMALIZE. THE FACILITY TRIED TO DISCONNECT AND RECONNECT WITHOUT SUCCESS. NO DAMAGE WAS OBSERVED DURING PREP. NO RESISTANCE WAS FELT AT ANY TIME DURING THE PROCEDURE. DEVICE WAS INSERTED THROUGH THE GUIDING CATHETER TO LAD. THE GUIDE WIRE (GW) AND GUIDE CATHETER (GC) WERE REMOVED AS A SYSTEM. ALL PORTIONS OF THE DEVICE APPEARED ACCOUNTED FOR AFTER REMOVAL FROM THE PATIENT AND NO DAMAGE WAS OBSERVED. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE FROM MANUFACTURER WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY. PATIENT WAS DISCHARGED AS EXPECTED. CONDITION TODAY WAS NOTED AS "GOOD." VESSEL: LAD CALCIFIED, RTG MODERATELY (CCA 50%) SEVERE STENOSIS. VISUAL AND MICROSCOPIC INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE PRESSURE SENSOR WAS BROKEN AND THE DISTAL END OF THE SENSOR WAS MISSING. THE REMAINING PORTION OF THE SENSOR WAS LEVEL IN THE SENSOR HOUSING. AN ELECTRICAL RESISTANCE TEST WAS PERFORMED. THE TEST DISCOVERED OPEN CONNECTIONS BETWEEN ALL THREE CONDUCTIVE BANDS. THE WIRE FAILED THE SIGNAL TEST AND WAS NOT RECOGNIZED. NO PRESSURE SIGNAL WAS GENERATED. DURING FUNCTIONAL TESTING, THE REPORTED FAILURE WAS DUPLICATED. THE PROBABLE CAUSE OF THE OBSERVED FAILURE WAS OPEN CONNECTIONS IN THE ELECTRICAL CIRCUIT OF THE DEVICE, DUE TO THE BROKEN SENSOR. HOWEVER, WE WERE UNABLE TO CONCLUSIVELY DETERMINE WHEN AND HOW THE SENSOR WAS BROKEN. 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
    700001 VERRATA PRESSURE GUIDE WIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORPORATION 10185 0243 50059870

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR