BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS VALVE

    MDR report key: 7973619 · Received October 17, 2018

    Report

    Report Number
    3001587388-2018-18487
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Date of Event
    September 21, 2018
    Report Date
    December 10, 2018
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    PMA / PMN Number
    K091328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OUR MANUFACTURING FACILITY TO BE ANALYZED FOLLOWING OUR QUALITY PROCEDURE. THE RETURNED DEVICE DOES NOT PRESENT DEPOSITS INSIDE THE BODY OF THE VALVE, WITH CLEAR LIQUID INSIDE. THE ORIGIN OF CATHETERS IS UNKNOWN BY SOPHYSA (LENGHT AROUND 220 MM). THE CATHETER HAS BEEN SUTURED TO THE OUTPUT OF ANTISIPHON. THE INTERNAL MECANISM DOES NOT PRESENT VISUAL ANOMALIES. A MARK ON THE ANTI-SIPHON IS VISIBLED. THE CATHETER HAVE BEEN TESTED AND DO NOT PRESENT OBSTRUCTION. FUNCTIONAL TESTING WAS PERFORMED ON THE SYSTEM IN ORDER TO VERIFY THE FUNCTIONING. THE ABILITY OF THE VALVE TO PERFORM WAS TESTED. IN THE STATE OF RETURN, THE VALVE IS POSSIBLE TO FLUSH WITH AIR. IT CONFIRMS THAT THERE IS NO OBSTRUCTION. THE ABILITY TO TURN THE ROTOR WAS TESTED UPON RETURN AND AFTER CLEANING. THE ROTATION IS POSSIBLE BOTH BEFORE AND AFTER CLEANING. ALL OPERATING PRESSURES OF THE VALVE AND THE ANTISIPHON HAVE BEEN MEASURED, THE PRESSURES ARE COMPLIANT. THE VALVE IS 100% CONTROLLED (PRESSURE/FLOW CHARACTERISTICS, VISUAL CONTROLS, ETC.) DURING THE MANUFACTURING. A REVIEW OF THE FABRICATION RECORD SHOWED NO ANOMALIES. IN CONCLUSION, THE RETURNED DEVICE ( VALVE AND ANTISIPHON ) DOES NOT HAVE ANY ANOMALIES,THE ROOT CAUSE COULD NOT BE DETERMINED. THE ISSUE FACED BY THE USER COULD NOT BE REPRODUCED UNDER LABORATORY CONDITIONS.

    Description of Event or Problem · 0

    THE USER INDICATES US THAT THE PATIENT WITH CHRONIC HYDROCEPHALUS SYMPTOMS WAS IMPLANTED WITH AN ADJUSTABLE VALVE PREATTACHED WITH SIPHON-X ON (B)(6) 2018. THE USER DECIDED TO EXPLANTE THE VALVE ON (B)(6) 2018 BECAUSE THE SIPHON X DID NOT SEEM TO WORK CORRESPONDING TO THE PATIENT POSITION.

    Description of Event or Problem · 1

    THE USER INDICATES US THAT THE PATIENT WITH CHRONIC HYDROCEPHALUS SYMPTOMS WAS IMPLANTED WITH AN ADJUSTABLE VALVE PREATTACHED WITH SIPHON-X ON (B)(6) 2018. THE USER DECIDED TO EXPLANT THE VALVE ON (B)(6) 2018 BECAUSE THE SIPHON X DID NOT SEEM TO WORK CORRESPONDING TO THE PATIENT POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813799 POLARIS VALVE POLARIS ADJUSTABLE VALVE JXG SOPHYSA SA SPVA-SX E0364

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention