BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSA VALVE

    MDR report key: 8350930 · Received February 19, 2019

    Report

    Report Number
    3004721439-2019-00036
    Event Type
    Injury
    Date Received
    February 19, 2019
    Date of Event
    January 25, 2019
    Report Date
    October 9, 2019
    Manufacturer
    B. BRAUN SURGICAL SA
    Product Code
    JXG
    PMA / PMN Number
    K120559
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012 PLEASE PROVIDED THE PATIENT OUTCOME AND MEDICAL INTERVENTION. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: VISUAL INSPECTION NO SIGNIFICANT DEFORMATIONS OR DAMAGE WERE DETECTED. PERMEABILITY TEST A PERMEABILITY TEST HAS SHOWN THAT BOTH VALVES ARE PERMEABLE. ADJUSTMENT TEST THE PROGAV VALVE WAS TESTED AND IS NOT ADJUSTABLE THROUGHOUT THE NORMAL RANGE. BRAKING FORCE AND BRAKE FUNCTION TEST THE BRAKE FUNCTIONALITY TEST HAS SHOWN THAT THE BRAKE FUNCTION OPERATES AS EXPECTED. HOWEVER, BECAUSE THE VALVE IS NOT ABLE TO HOLD A SET PRESSURE, THE BRAKE FORCE COULD NOT BE MEASURED. WE HAVE DISMANTLED THE VALVE. INSIDE BOTH VALVES, WE HAVE FOUND BUILD-UP OF SUBSTANCES (LIKELY PROTEIN). BASED ON OUR INVESTIGATION, WE CONFIRM THAT THE VALVE IS NON-ADJUSTABLE, LIKELY DUE TO THE DEPOSITS OBSERVED INSIDE THE VALVE. AS DESCRIBED IN OUR LITERATURE, THE PROBLEM ENCOUNTERED IS ONE OF THE KNOWN, INEVITABLE RISKS OF HC-THERAPY BY SHUNT IMPLANTS. WE CAN EXCLUDE A DEFECT AT THE TIME OF RELEASE. THE SHUNT SYSTEM MET ALL SPECIFICATIONS OF THE FINAL INSPECTION WHEN RELEASED FROM CHRISTOPH MIETHKE GMBH & CO. KG.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THE VALVE WAS NOT ADJUSTABLE. THE EXPLANTED PRODUCT WERE DELIVERED TO MIETHKE WITH THE RETURN KIT INSIDE AN UNKNOWN LIQUID. PLEASE PROVIDE THE PATIENT OUTCOME AND THE MEDICAL INTERVENTION. THE FILE WAS ENTERED WITH LIMITED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142792 PROSA VALVE HYDROCEPHALUS AND ICP MANAGEMENT JXG B. BRAUN SURGICAL SA FV701T 20028836

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other| R