BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNTASSISTANT (25)

    MDR report key: 20704986 · Received November 18, 2024

    Report

    Report Number
    3004721439-2024-00371
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Report Date
    December 4, 2024
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906113308
    PMA / PMN Number
    K110206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: VISUAL INSPECTION: DURING THE INVESTIGATION, DRY CRISTALINE VISIBLE DEPOSITS IN THE INLET/OUTLET SPOUT WERE DETERMINED. PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT THE VALVE IS PERMEABLE. COMPUTER CONTROLLED TEST: TO INVESTIGATE THE CLAIM OF MADE BY THE CUSTOMER: "DID NOT RESIST TO SCF FLOW IN VERTICAL POSITION - PREOPERATIVE", THE OPENING PRESSURE IS MEASURED USING A MIETHKE COMPUTER CONTROLLED TESTING APPARATUS WHICH SIMULATES A CEREBROSPINAL FLUID FLOW. THE VALVE IS TESTED IN BOTH THE HORIZONTAL AS WELL AS THE VERTICAL POSITIONS. THE RESULTS SHOW THAT THE VALVE IS NOT OPERATING WITHIN THE ACCEPTED TOLERANCE IN THE VERTICAL POSITION. A TENDENCY TO AN ACCELERATED OUTFLOW COULD BE DETERMINED. INTERNAL INSPECTION: AFTER DISMANTLING OF THE VALVE, NO DEPOSITS WERE FOUND. RESULTS: PLEASE NOTE - THE VALVE WAS TESTED BEFORE USE WITH SALINE SOLUTION. AFTER THE TESTING THE VALVE WAS NOT INSERTED IN SOLUTION AND WAS RETURNED IN DRY CONDITION WITH A CLEAR DELAY. THE TESTING OF DRY PRODUCTS IS OF LIMITED VALUE. A DRIED-UP SALINE SOLUTION CAN LEAD TO INVALID TEST RESULTS. BASED ON OUR TEST RESULTS, WE CAN DETERMINE DRY VISIBLE DEPOSITS IN THE SPOUTS AND A TENDENCY TO AN ACCELERATED OUTFLOW AT THE VALVE IN VERTICAL POSITION. OPENING VALVES ALLOWS A VIEW OF A SIGNIFICANT PART OF THE INTERIOR. NEVERTHELESS, THERE ARE AREAS WHICH EVADE VISUAL INSPECTION. IN THESE PARTS, IT IS ALSO POSSIBLE TO HAVE DRY DEPOSITS WHICH CAN INFLUENCE THE FUNCTION OF THE VALVE. THE EXAMINATION OF THE RETURN PRODUCT HAS BEEN COMPLETED WITH THE DRAFTING OF THIS REPORT. 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. NO FURTHER REGULATORY ACTIONS ARE REQUIRED FROM OUR POINT OF VIEW.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: TRACEABILITY OF PRODUCTION DATA WAS PERFORMED AND SHOWED NO DEVIATION. THE INVESTIGATION IS ON-GOING. SHOULD THE INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SHUNTASSISTANT (#FV252T) WAS TESTED PREOPERATIVELY AND SHOWED UNEXPECTED BEHAVIOR. NO PATIENT INVOLVEMENT. THE INCIDENT WAS REPORTED TO THE MANUFACTURER LATE ON NOVEMBER 13, 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2610429 SHUNTASSISTANT (25) HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FV252T 20052979 04041906113308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown