BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGAV 2.0 WITH SA25 AND DISTAL CATHETER

    MDR report key: 7895295 · Received September 20, 2018

    Report

    Report Number
    3004721439-2018-00235
    Event Type
    Malfunction
    Date Received
    September 20, 2018
    Date of Event
    August 24, 2018
    Report Date
    September 12, 2019
    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

    WE RECEIVED THE SHUNT SYSTEM IN A RETURNKIT. THE VALVE WAS SUBMERGED IN AN UNKNOWN LIQUID. THE PROGAV2.0 VALVE WAS AT A PRESSURE SETTING OF 0. THE FIRST STEP OF OUR INVESTIGATION IS AN OPTICAL INSPECTION. WE FOUND SCRATCHES ON THE VALVE HOUSING BUT DID NOT DETECT ANY OBVIOUS DEFORMATIONS OR OTHER ABNORMALITIES. LIGATURE THREAD WAS FOUND ON THE CATHETER. THE LIGATURE THREAD IS NOT A PRODUCT FROM MIETHKE GMBH & CO. KG. TO FIND OUT IF THE CATHETER HAD A HOLE, WE PERFORMED A VISUAL INVESTIGATION UNDER A MICROSCOPE. NO DAMAGE TO THE CATHETER WAS DETECTED. TO PROOF THE PENETRABILITY OF THE VALVE, WE CARRIED OUT A PERMEABILITY TEST. THIS TEST WAS CARRIED OUT AT A HYDROSTATIC PRESSURE DIFFERENCE OF APPROXIMATELY 20-30 CMH2O IN THE DIRECTION OF FLOW. THE TEST RESULTS SHOWED THAT BOTH THE PROGAV2.0 VALVE AND THE CATHETER WERE PENETRABLE. FURTHERMORE, WHEN FLUSHING THE CATHETER WITH TEST FLUID, WE HAVE FOUND NO LEAKAGE. ADJUSTMENT TESTS ARE CARRIED OUT WITH THE STANDARD PROGAV2.0 CHECK-MATE AND MEASUREMENT TOOL. THE VALVE IS ADJUSTED FROM 0 TO 20 CMH2O AND DOWN AGAIN IN INCREMENTS OF 5 CMH2O. THE TEST SHOWED THAT THE VALVE IS ADJUSTABLE TO ALL SETTINGS. 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 TO RELEASE THE ROTOR TO ADJUST THE VALVE BY THE INTEGRATED MAGNET OF THE BRAKING FORCE APPARATUS. THE INVESTIGATION OF THE BRAKING FORCE HAS SHOWN THAT THE BRAKE FUNCTION IS FULLY OPERATIONAL. BASED ON OUR INVESTIGATION RESULTS WE CANNOT CONFIRM A BLOCKAGE OF THE SHUNT SYSTEM OR LEAKAGE OF THE CATHETER. WE SUSPECT THAT THE DEPOSITS OF PROTEIN FOUND IN THE PAEDISA VALVE AND ON THE SPOUT COULD HAVE LED TO A BLOCKAGE OF THE SHUNT SYSTEM IN THE PAST. NO FURTHER ACTIONS ARE REQUIRED.

    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. IMPLANT DATE: UNKNOWN. PENDING FURTHER INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL TO THE COMPANY SALES REPRESENTATIVE "THE VALVE WAS REMOVED DUE TO INFECTION AFTER IMPLANT. WHEN CHECKING THE PRODUCT AFTER REMOVING, THE LEAKAGE SEEMED TO OCCUR, HOWEVER THE POSITION OF LEAKAGE WAS NOT FOUND. ADDITIONAL INFORMATION: THE PATIENT GOT INFLAMMATION, POSSIBLY CAUSED BY THE LEAKAGE. THEREFORE, THE REVISION SURGERY WAS DONE. THE PATIENT DOES NOT HAVE INFECTION. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 3004721439-2018-00235 (THIS REPORT); 3004721439-2018-00236.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734303 PROGAV 2.0 WITH SA25 AND DISTAL CATHETER HYDROCEPHALUS VALVES JXG CHRISTOPH MIETHKE GMBH & CO. KG FX421T

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention