BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIGAV SYSTEM WITH PRECHAMBER

    MDR report key: 8080321 · Received November 16, 2018

    Report

    Report Number
    3004721439-2018-00266
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Report Date
    July 18, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    PMA / PMN Number
    K031303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY PER FDA REQUEST. MANUFACTURING SITE INVESTIGATION: THE UNIGAV VALVE WITH PRECHAMBER WAS RECEIVED DRY. THE OUTER PACKAGE WAS OPENED AND HEAVILY SOILED. THE VISUAL INSPECTION NOTED THAT THE CATHETER AND THE ANCHOR THAT ASSIST IN THE CONNECTION BETWEEN THE CATHETER AND THE INTAKE SPOUT OF THE PRECHAMBER WERE SEPARATED FROM THE PRECHAMBER. THE HOUSING, WHICH CLAMPS THE ANCHOR AND CATHETER TO THE PRECHAMBER, WAS STILL ATTACHED TO THE PRECHAMBER AND SHOWED REMAINS OF THE CATHETER INSIDE THE SPOUT. THE CATHETER END WAS ALSO OBSERVED TO BE NON-UNIFORM INDICATING A BREAKAGE OR TEAR. A VISUAL INSPECTION WAS PERFORMED OF THE CONNECTION BETWEEN THE CATHETER AND THE PRECHAMBER CONNECTOR. UNDER MICROSCOPIC INSPECTION THE CATHETER END WAS SHOWN TO BE WAVY AND THE PRECHAMBER CONNECTOR HAD REMAINS FROM THE CATHETER INSIDE THE END OF THE SPOUT. DURING THE MANUFACTURING PROCESS, THE CATHETER IS CONNECTED TO THE PRECHAMBER VIA AN ANCHOR INSERTED INTO THE END OF THE CATHETER. THIS IS THEN INSERTED INTO THE INTAKE SPOUT OF THE PRECHAMBER AND PRESSED INTO PLACE USING A METAL HOUSING RING. THIS CONNECTION IS INTENDED TO BE PERMANENT AND GREAT FORCE IS REQUIRED TO REMOVE THE CATHETER FROM THE CONNECTOR. THE FINDINGS INDICATE THAT THE CATHETER WAS PULLED WITH FORCE FROM THE CONNECTOR CAUSING THE DEFECT. IT IS UNCLEAR THROUGH OUR INVESTIGATION HOW IT OCCURRED. THE PRODUCT MET ALL SPECIFICATIONS OF THE FINAL INSPECTION DURING THE MANUFACTURING PROCESS.

    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. REPORTED DEVICE NOT MARKETED IN THE U.S.; HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. DATE OF EVENT: UNKNOWN. 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 THAT "AFTER OPENING THE OUTER PACKAGE THE OUTLET PART OF THE RESERVOIR WAS DETACHED. THE DEVICE WAS NOT USED 'IN' THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918707 UNIGAV SYSTEM WITH PRECHAMBER HYDROCEPHALUS VALVES JXG CHRISTOPH MIETHKE GMBH & CO KG FV555-T 20034667

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown