BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION VALVE INLINE, SIPHONGUARD

    MDR report key: 5551929 · Received April 6, 2016

    Report

    Report Number
    1226348-2016-10270
    Event Type
    Malfunction
    Date Received
    April 6, 2016
    Date of Event
    March 16, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE VALVE IS A PRECISION VALVE WITH 3 DOTS. THE VALVE WAS VISUALLY INSPECTED: NEEDLE HOLES IN THE NEEDLE CHAMBER WERE NOTED. THE VALVE WAS IRRIGATED WITH PURIFIED WATER. NO OCCLUSION WAS NOTED. THE SIPHON GUARD WAS IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE CATHETERS WERE IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED, ONLY LEAKED FROM THE NEEDLE HOLES IN THE NEEDLE CHAMBER. THE SIPHON GUARD WAS REMOVED FOR PRESSURE TESTING. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3813 WITH LOT CPNBG0, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 10TH APRIL 2014. NO ROOT CAUSE COULD BE DETERMINED AS THE PROBLEM REPORTED BY THE CUSTOMER WAS NOT CONFIRMED. THE VALVE FUNCTIONED. THE PROBLEM WAS LIKELY DUE TO AN EXCESSIVE FLOW RATE (>0.75 ML/MIN) DURING THE FLUSHING PROCEDURE ACTIVATES THE SIPHON GUARD AND CREATES THE IMPRESSION THAT THE VALVE IS DISTALLY OCCLUDED. IN REALITY THE FLOW IS BEING DIVERTED TO THE HIGH RESISTANCE SECONDARY PATHWAY, THIS WILL SLOW THE RATE AT WHICH CSF IS SHUNTED FROM THE BRAIN. IT WOULD PROBABLY EXPLAIN THE PROBLEM ENCOUNTERED BY THE CUSTOMER. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    INTRAOPERATIVE VALVE OCCLUSION. DURING VP SURGERY IT WAS NOTED NO CEREBROSPINAL FLUID DRAINED. THE SURGEON TRIED MANY TIMES BUT FAILED. CHANGED THE NEW DEVICE TO COMPLETE. THE PATIENT CONDITION IS STABLE. THERE WAS NO ADVERSE EVENT OR EXTENDED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207845 PRECISION VALVE INLINE, SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CRCC0G

    Patients

    Seq Age Sex Outcome Treatment
    1