BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 SYS PED.W/SA20 A.PRECHAMBER

    MDR report key: 16098909 · Received January 4, 2023

    Report

    Report Number
    3004721439-2022-00405
    Event Type
    Injury
    Date Received
    January 4, 2023
    Date of Event
    December 1, 2022
    Report Date
    January 4, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906137465
    PMA / PMN Number
    K161853
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: VISUAL INSPECTION: IN THE FIRST STEP OF OUR INVESTIGATION, WE PERFORMED A VISUAL INSPECTION OF THE PRODUCT. WE HAVE CHECKED FOR POSSIBLE DAMAGE, DEFORMATION OF THE HOUSING, DEPOSITS OR OTHER ABNORMALITIES. THE FOLLOWING OBSERVATIONS WERE MADE DURING THE VISUAL INSPECTION: DEPOSITS AND SCRATCHES ON THE PROGAV 2.0; DEPOSITS INSIDE AND OUTSIDE OF THE PRECHAMBER. PERMEABILITY TEST: THE PERMEABILITY TEST WAS PERFORMED AT A HYDROSTATIC PRESSURE DIFFERENCE OF THE PRESSURE SETTING OF THE PROGAV 2.0 UPON RECEIPT PLUS 30 CMH2O IN THE HORIZONTAL DIRECTION OF FLOW. THE TEST SHOWED THAT THE PROGAV 2.0 SHUNT SYSTEM IS PERMEABLE. OMPUTER CONTROL TEST: TO CHECK THE FLOW RATE OF THE VALVES, THE VALVES WERE TESTED ON A MIETHKE COMPUTER CONTROLLED TESTING APPARATUS AND PASSED THE STANDARD TEST. THE FLOW OF THE TEST LIQUID WAS REDUCED STEP BY STEP FROM 60 ML/H TO 5 ML/H (IN ACCORDANCE WITH ISO 7197). DISTILLED WATER WAS USED AS THE TEST-LIQUID. THE RESULTING PRESSURE WAS MEASURED. THE COMPUTER CONTROLLED TEST SHOWED THE OPENING PRESSURE OF THE PROGAV 2.0, AT A REFERENCE FLOW RATE OF 20 ML/H IN A HORIZONTAL POSITION, TO BE 6,36 CMH2O. THIS IS NOT WITHIN THE SPECIFIED TOLERANCE OF 10 CMH2O ± 3 CMH2O. ACCORDING TO OUR RESULTS, WE CAN DETECT AN ACCELERATED OUTFLOW. ADDITIONALLY, THE SHUNTASSISTANT WAS TESTED ACCORDING TO STANDARD PROCEDURE IN THE VERTICAL POSITION. THE RESULTS INDICATED THAT AT A REFERENCE FLOW OF 20 ML/H IN THE VERTICAL POSITION, THE SHUNTASSISTANT HAD A PRESSURE OF 16,67 CMH2O. THIS IS NOT WITHIN THE SPECIFIED TOLERANCE OF 20 CMH2O -2/+4 CMH2O. ADJUSTABILITY TEST: IN THIS STEP, IT WAS INVESTIGATED WHETHER THE ADJUSTABLE PROGAV 2.0 CAN BE SUCCESSFULLY SET TO EACH SPECIFIED PRESSURE SETTING. IT WAS CHECKED WHETHER THE VALVE IS FULLY ADJUSTABLE WITHIN THE FULL RANGE OF SPECIFIED PRESSURE SETTINGS (IN INCREMENTS OF 5 CMH2O). THE PROGAV 2.0 WAS FOUND TO BE ADJUSTABLE TO ALL PRESSURE SETTINGS. THE SHUNTASSISTANT IS A FIXED PRESSURE VALVE, THEREFORE THE ADJUSTABILITY TEST IS INAPPLICABLE. BRAKING FORCE AND BRAKE FUNCTION TEST: THE BRAKING FORCE AND BRAKE FUNCTION TEST INVESTIGATES WHETHER THE BRAKE FUNCTION OF THE ADJUSTABLE VALVES IS PRESENT AND HOW MUCH FORCE MUST BE EXERTED ON THE HOUSING TO RELEASE THE ROTOR TO ADJUST THE VALVES USING THE INTEGRATED MAGNET OF A SPECIFIC MEASUREMENT APPARATUS OF BRAKING FORCE. THE BRAKING FORCE OF THE PROGAV 2.0 WAS WITHIN THE SPECIFIED TOLERANCE AND THE BRAKE FUNCTION OPERATED AS EXPECTED. INTERNAL INSPECTION OF PRODUCT: IN ORDER TO VERIFY WHETHER THE INVESTIGATED SHUNT SYSTEM WAS COMPROMISED BY THE KNOWN RISKS OF HYDROCEPHALUS THERAPY, E.G. BY A BUILD-UP OF NATURAL SUBSTANCES (PROTEIN, BLOOD, OR TISSUE PARTICLES) IN THE CEREBROSPINAL FLUID, THE VALVES ARE FINALLY OPENED WITH A SPECIAL TOOL. AFTER DISMANTLING OF THE VALVES, DEPOSITS WERE FOUND IN BOTH VALVES. FOR MORE DETAILED VISIBILITY, THE PROTEINS/DEPOSITS IN THE PROGAV 2.0 AND THE SHUNTASSISTANT WERE COLOURED BY USING A COLOURING SOLUTION. [COLOURING SOLUTION CONSISTING OF COOMASSI BRILLIANT BLUE R MIXED WITH (B)(4) ETHANOL AND DISTILLED WATER]. RESULTS: BASED ON OUR INVESTIGATION RESULTS, WE HAVE DETERMINED THAT THERE WAS AN ACCELERATED OUTFLOW IN THE VALVE AT THE TIME OF OUR INVESTIGATION. DETECTED DEPOSITS WERE THE CAUSE OF THE ACCELERATED OUTFLOW ENDOGENOUS SUBSTANCES IN THE CSF CAN TEMPORARILY IMPAIR THE FUNCTION OF THE VALVE AND IS DESCRIBED AS CONCOMITANT SYMPTOMS IN HYDROCEPHALUS THERAPY. WE CAN EXCLUDE A DEFECT AT THE TIME OF RELEASE. THE SHUNT SYSTEM MET ALL SPECIFICATIONS OF THE FINAL INSPECTION WHEN RELEASED FROM CHRISTOPH MIETHKE GMBH & CO. KG. FURTHER ACTIONS: FROM OUR POINT OF VIEW, NO FURTHER REGULATORY ACTIONS ARE REQUIRED. RETURN OF PRODUCT: WE WILL RETURN THE INVESTIGATED PRODUCT TO THE SENDER FOR OUR OWN RELIEF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROSA (#FX441T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2022. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 6 YEARS, 4 MONTHS; HEIGHT: 120 CENTIMETERS (CM); WEIGHT: 15 KILOGRAMS (KG); GENDER: MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419745 PROGAV 2.0 SYS PED.W/SA20 A.PRECHAMBER HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FX441T 20043863 04041906137465

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Required Intervention