BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 WITH SHUNTASSISTANT 25

    MDR report key: 8349703 · Received February 19, 2019

    Report

    Report Number
    3004721439-2019-00032
    Event Type
    Injury
    Date Received
    February 19, 2019
    Date of Event
    January 19, 2019
    Report Date
    October 9, 2019
    Manufacturer
    B. BRAUN SURGICAL SA
    Product Code
    JXG
    PMA / PMN Number
    K141687
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION VISUAL INSPECTION SCRATCHES ON THE OUTER HOUSING OF VALVES WERE OBSERVED THROUGH THE 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 2.0 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 IS OPERATIONAL; HOWEVER, THE BREAKING FORCED CANNOT BE MEASURED DUE TO THE NON-ADJUSTABILITY OF THE VALVE. DUE TO THE INABILITY OF THE VALVE TO HOLD A SET PRESSURE, IT WAS NOT POSSIBLE TO MEASURE THE BAKE FORCE. WE HAVE DISMANTLED THE VALVE. INSIDE BOTH VALVES, WE HAVE FOUND BUILD-UP OF SUBSTANCES (LIKELY PROTEIN). BASED ON OUR INVESTIGATION, WE ARE UNABLE TO SUBSTANTIATE THE CLAIM OF OCCLUSION. BOTH VALVES WERE SHOWN TO BE PERMEABLE. HOWEVER, IT IS POSSIBLE THAT THE DEPOSITS OBSERVED INSIDE THE VALVES COULD HAVE TEMPORARILY OCCLUDED THE SYSTEM IN THE PAST AS WELL AS LED TO THE OBSERVED NON-ADJUSTABILITY OF THE PROGAV 2.0. 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.

    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 PROVIDE THE PATIENT'S AGE, GENDER, WEIGHT, OUTCOME AND MEDICAL INTERVENTION. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL "8M PO BLOCKED VALVE". PATIENT IS 92CM, 14,6KG, GENDER UNKNOWN. THE EXPLANTED PRODUCT WERE DELIVERED TO MIETHKE WITH THE RETURN KIT INSIDE AN UNKNOWN LIQUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142434 PROGAV 2.0 WITH SHUNTASSISTANT 25 HYDROCEPHALUS AND ICP MANAGEME JXG B. BRAUN SURGICAL SA FX414T 20036567

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other| R