BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSA VALVE

    MDR report key: 7839775 · Received August 31, 2018

    Report

    Report Number
    3004721439-2018-00194
    Event Type
    Malfunction
    Date Received
    August 31, 2018
    Date of Event
    March 20, 2018
    Report Date
    October 31, 2018
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K161853
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: EVALUATION ON-GOING. PENDING FURTHER INFORMATION.

    Additional Manufacturer Narrative · 0

    ALL MEDWATCH SUBMISSIONS RELATED TO THIS REPORT: 3004721439-2018-00177, 3004721439-2018-00194 (THIS REPORT) MANUFACTURING AND QUALITY CONTROL DATA: THE VALVE WAS MANUFACTURED BY A QUALIFIED EMPLOYEE IN AUGUST 2016. DEVIATIONS DURING ASSEMBLY DID NOT OCCUR. THE VALVE WAS STERILIZED BY MIETHKE AND RELEASED FOR SHIPMENT AFTER FINAL INSPECTION. THE PROGAV2.0 VALVE HAS A NOMINAL PRESSURE RANGE OF 0 TO 20 CMWS. THE VALVE SPECIFICATIONS AFTER FINAL INSPECTION HAVE BEEN PASSED. THE VALVE WAS INSPECTED AS ARTICLE FX438T. ALL PARAMETERS (OPENING PRESSURE, REFLUX, TIGHTNESS, ADJUSTABILITY AND BRAKE FUNCTION) HAVE BEEN INSPECTED AND SIGNED DURING THE MANUFACTURING PROCESS. INVESTIGATION: OPTICAL INSPECTION: FIRST STEP OF OUR INVESTIGATION IS THE OPTICAL INSPECTION. WE CAN SEE SCRATCHES BUT NOT DETECT ANY OBVIOUS DEFORMATIONS OR OTHER ABNORMALITIES THE PROGAV2.0 VALVE. PERMEABILITY TEST: TO PROOF THE PENETRABILITY WE CARRIED OUT A PERMEABILITY TEST. THIS TEST WAS CARRIED OUT AT A HYDROSTATIC PRESSURE DIFFERENCE OF APPROX. 20-30 CMH2O IN THE FLOW DIRECTION. THE INVESTIGATION HAS SHOWN THAT THE PROGAV2.0 VALVE WAS PERMEABLE. ADJUSTMENT TEST: OUR ADJUSTMENT TESTS ARE CARRIED OUT WITH THE STANDARD PROGAV2.0 CHECK MATE AND MEASUREMENT TOOL. THE VALVE IS ADJUSTED FROM 0 UP TO 20 CMH2O AND DOWN AGAIN IN THE SAME WAY IN STEPS OF 5 CMH2O. IT WAS FOUND THAT NO ADJUSTMENT WAS POSSIBLE. BRAKING FORCE AND BRAKE FUNCTION TEST: TO MEASURE THE BRAKING FORCE WE HAVE INVESTIGATED THE VALVE WITH A BRAKING FORCE APPARATUS. HERE IT IS MEASURED HOW MUCH FORCE MUST BE EXERTED ON THE HOUSING OF THE PROGAV2.0 VALVE TO RELEASE THE ROTOR TO ADJUST THE VALVE BY THE INTEGRATED MAGNETS. THE MEASUREMENT OF THE BRAKING FORCE COULD NOT BE INVESTIGATED BECAUSE IT WAS NOT POSSIBLE TO ADJUST THE VALVE AS DESCRIBED UNDER POINT "3.6 ADJUSTMENT TEST". RESULT: FIRST WE PERFORMED A VISUAL INSPECTION ON THE PROGAV2.0 VALVE. APART FROM SCRATCHES ON THE HOUSING, WE COULD NOT DETECT ANY DEFORMATIONS OR OTHER ABNORMALITIES. TO ENSURE THAT THE VALVE IS PENETRABLE WE HAVE CARRIED OUT PERMEABILITY TEST. THE INVESTIGATION HAS SHOWN THAT THE VALVE WAS PENETRABLE. IN THE NEXT STEP WE HAVE CARRIED OUT ADJUSTMENT TEST. WE TRIED TO ADJUST THE VALVE FROM 0 CMH2O UP TO 20 CMH2O AND DOWN AGAIN IN THE SAME WAY IN STEPS OF 5CMH2O. IT WAS NOT POSSIBLE TO ADJUST THE VALVE IN THE PRESSURE SETTINGS. TO PROOF IF THE BRAKE FUNCTION IS FULL IN PLACE WE CARRIED OUT A BRAKE FUNCTION TEST. THE MEASUREMENT OF THE BRAKING FORCE COULD NOT BE INVESTIGATED BECAUSE IT WAS NOT POSSIBLE TO ADJUST THE VALVE AS DESCRIBED UNDER POINT "3.6 ADJUSTMENT TEST" IN ORDER TO VERIFY WHETHER THE VALVES WERE INFLUENCED BY THE KNOWN RISKS OF HYDROCEPHALUS THERAPY, AS FOR EXAMPLE BY NATURAL SUBSTANCES (PROTEIN, BLOOD OR TISSUE PARTICLES)1 IN THE CEREBROSPINAL FLUID, WE HAVE FINALLY OPENED THE VALVES. AFTER OPENING THE PROGAV2.0 WE FOUND INTENSE DEPOSITS INSIDE THE VALVE, BASED ON OUR INVESTIGATION RESULTS WE CANNOT CONFIRM THAT THE PROGAV2.0 WAS BLOCKED. HOWEVER, WE COULD DETERMINE THAT IT WAS NOT POSSIBLE TO ADJUST THE VALVE. WE SUSPECT THAT THE FOUND DEPOSITS COULD HAVE AFFECTED THE FUNCTION OF THE VALVE. FURTHER ACTIONS NO FURTHER ACTIONS ARE REQUIRED FROM OUR POINT OF VIEW. THERE IS NO FAILURE DETECTABLE WITH THIS VALVE AT THE TIME OF DISTRIBUTION. CLARIFICATION HAS BEEN REQUESTED REGARDING THE EVENT DATE, HOWEVER, NOT YET RECEIVED. A CLARIFICATION HAS BEEN REQUESTED REGARDING PERMEABILITY TESTING. IF ANY CHANGES TO THE INVESTIGATION ARE FOUND, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL TO THE COMPANY SALES REPRESENTATIVE "DUE TO THE BLOCKAGE OF VALVE, REVISION SURGERY WAS DONE (B)(6) 2018." ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 3004721439-2018-00177 , 3004721439-2018-00194 (THIS REPORT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679460 PROSA VALVE HYDROCEPHALUS VALVES JXG CHRISTOPH MIETHKE GMBH & CO. KG FV701T 20032359

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention