BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAV W.DISTAL CATH.10/40

    MDR report key: 8487802 · Received April 5, 2019

    Report

    Report Number
    3004721439-2019-00082
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    March 13, 2019
    Report Date
    April 29, 2019
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K031303
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF CHRISTOPH MIETHKE GMBH & CO. KG (MANUFACTURER, REGISTRATION NO. 3004721439). EXEMPTION NUMBER: E2017044 MANUFACTURING SITE EVALUATION: VISUAL INSPECTION - NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE VALVE WERE DETECTED DURING INSPECTION. IT WAS NOTED DURING OBSERVATION THAT THE CATHETER WAS NOT SECURELY ATTACHED TO THE VALVE. PERMEABILITY TEST- THE TEST HAS INDICATED THAT THE VALVE HAS A BLOCKAGE. ADJUSTMENT TEST AND BRAKING FORCE/FUNCTION - THIS IS A FIXED PRESSURE VALVE. THESE TESTS ARE NOT APPLICABLE. RESULTS - AFTER THE ABOVE TESTS, WE HAVE DISMANTLED THE VALVE. INSIDE THE VALVE WE HAVE FOUND A BUILD-UP OF SUBSTANCES (LIKELY PROTEIN). WE WERE UNABLE TO CLOSELY INVESTIGATE THE CLAIM OF OVER-DRAINAGE BECAUSE THE VALVE IS NOT PERMEABLE, AND THEREFORE A COMPUTER-CONTROLLED TEST WAS NOT POSSIBLE. BASED ON OUR INVESTIGATION, WE CONFIRM THE PRESENCE OF OCCLUSION IN THE VALVE, LIKELY DUE TO 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 VALVE 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 CHRISTOPH MIETHKE GMBH & CO. KG (MANUFACTURER, REGISTRATION NO. 3004721439). EXEMPTION NUMBER: E2017044. SECTION A - PATIENT DATA - HEIGHT 180 CM. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A GAV VALVE WAS POSSIBLY BLOCKED. A PATIENT UNDERWENT A RETRO-AURICULAR SHUNT SYSTEM IMPLANTATION ON (B)(6) 2018. SOMETIME LATER, UNDERDRAINAGE WAS NOTED; AND THE PATIENT'S CEREBROSPINAL FLUID (CSF) PROTEIN COUNT WAS ALSO OBSERVED TO BE HIGH. ON (B)(6) 2019, THE SHUNT WAS REPLACED DUE TO THIS MALFUNCTION. FURTHER DETAILS WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278974 GAV W.DISTAL CATH.10/40 HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO. KG FV320T 20038426

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention