BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGAV 2.0 SYS PED.W/SA20 A.PRECHAMBER

    MDR report key: 7814442 · Received August 24, 2018

    Report

    Report Number
    3004721439-2018-00186
    Event Type
    Malfunction
    Date Received
    August 24, 2018
    Date of Event
    July 5, 2018
    Report Date
    October 31, 2018
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K141687
    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. DATE OF EXPLANT: UNKNOWN. PENDING FURTHER UNKNOWN.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE VALVE WAS MANUFACTURED BY A QUALIFIED EMPLOYEE IN NOVEMBER 2017. 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 FX441T. ALL PARAMETERS (OPENING PRESSURE, REFLUX, TIGHTNESS, ADJUSTABILITY AND BRAKE FUNCTION) HAVE BEEN INSPECTED AND SIGNED DURING THE MANUFACTURING PROCESS. 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 "DIFFICULTLY 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 OUT THAT EVERY 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 BRAKE FUNCTION TEST HAS RESULTED THAT THE BRAKE FUNCTION IS FULL IN PLACE. THE MEASUREMENT OF THE BRAKING FORCE IS INSIDE THE TOLERANCE. 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 "DIFFICULT 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. BASED ON OUR INVESTIGATION RESULTS WE CAN CONFIRM THAT IT WAS POSSIBLE TO ADJUST THE VALVE IN ALL PRESSURE SETTINGS. TO PROOF IF THE BRAKE FUNCTION IS FULL IN PLACE WE CARRIED OUT A BRAKE FUNCTION TEST. THE INVESTIGATION HAS SHOWN THAT THE BRAKE FUNCTION IS PRESENT. IN ORDER TO VERIFY WHETHER THE VALVE 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 VALVE. AFTER OPENING THE PROGAV2.0 VALVE WE FOUND DEPOSITS INSIDE THE VALVE. WE SUSPECT THAT THE 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 RECIEVED. CLARIFICATION HAS BEEN REQUESTED REGARDING PERMEABILITY TESTING. IF ANY CHANGES TO THE INVESTIGATION ARE FOUND, A SUPPLEMENTAL REPROT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL TO THE COMPANY SALES REPRESENTATIVE "THE PRIMARY SURGERY WAS DONE ON (B)(6) 2018. IN (B)(6), SUBDURAL HEMATOMA AND OVER-DRAINAGE WAS SEEN. THEREFORE, THE PRESSURE VALUE WAS CHANGED 5CMH2O TO 10CMH2O." AFTER THAT, THE VALUE WAS CHANGED 6CMH2O AGAIN DUE TO NO IMPROVEMENT IN PATIENT CONDITION. HOWEVER, THE VENTRICULAR SIZE WAS NOT CHANGED WITH 6CMH2O. THE SURGEON USED CONTRAST AGENT AND FOUND THAT THE AGENT DID NOT GO THROUGH RESERVOIR INTO ABDOMINAL CATHETER. ACCORDING TO PICTURE IMAGE, IT SEEMED THAT THE CONTRAST AGENT LEAKED FROM THE ABDOMINAL CATHETER. ADDITIONALLY, THE PATIENT HAS FREQUENTLY FALLEN AND LIKELY GOT IMPACT ON HEAD, THEREFORE, THE VALVE FUNCTION FAILURE IS ALSO SUSPICIOUS. WE WOULD LIKE TO HAVE THE RESULT OF INVESTIGATION AS BELOW; FUNCTION OF VALVE. THE BLOCKAGE. THE DAMAGE OF ABDOMINAL CATHETER. THE ACTUAL SAMPLE WILL BE DISPATCHED TO MIETHKE DIRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655952 PROGAV 2.0 SYS PED.W/SA20 A.PRECHAMBER HYDROCEPHALUS VALVES JXG CHRISTOPH MIETHKE GMBH & CO. KG FX441T 20035661

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention