BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION VALVE INLINT, SIPHONGUARD

    MDR report key: 4812732 · Received June 2, 2015

    Report

    Report Number
    1226348-2015-10316
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 8, 2015
    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: NO DEFECTS 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 CATHETER WAS IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED, NO LEAKS WERE NOTED. 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 CRFB26, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 14TH MAY 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, THIS HOWEVER COULD NOT BE DETERMINED. 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

    LIQUID WAS PUSHED FROM THE VENTRICULAR SIDE OF THE VALVE, BUT THERE WAS NOT ANY LIQUID OUTPUT FROM PERITONEAL END. HOWEVER IF THE LIQUID PUSHED WITH GREAT FORCE, THEN THERE WAS DRIPPING OUTPUT FROM PERITONEAL END. (B)(4) 2015 PER AFFILIATE: WAS THIS ISSUE FOUND BEFORE, DURING OR AFTER SURGERY? FOUND DURING SURGERY. WAS THE DEVICE IMPLANTED? NO DEVICE WAS NOT IMPLANTED. WAS THERE ANY PATIENT INJURY REPORTED? NO INJURIES WERE REPORTED. WAS THERE A DELAY IN SURGERY GREATER THAN 30 MINUTES REPORTED? THERE WAS NO DELAY. WAS ACTIONS WERE TAKEN AS A RESULT OF THIS ISSUE (SIMILAR VALVE USED TO COMPLETE PROCEDURE, VALVE WAS EXPLANTED, ETC.)? SIMILAR VALVE USED TO COMPLETE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355190 PRECISION VALVE INLINT, SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CRFB26

    Patients

    Seq Age Sex Outcome Treatment
    1