BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV SYS PED.W/SA 20 A.PRECHAMBER

    MDR report key: 17513640 · Received August 11, 2023

    Report

    Report Number
    3004721439-2023-00228
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    July 11, 2023
    Report Date
    August 11, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906132545
    PMA / PMN Number
    K103003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: DURING THE VISUAL INSPECTION A DEFORMATION OF THE OUTER HOUSING OF THE PROGAV VALVE COULD BE DETERMINED. THE MEASUREMENT OF THE PLANE PARALLELISM COULD CONFIRM THAT WITH A VALUE OF -0,100 MM - OUTSIDE TOLERANCE (0 ± 0.02 MM). DEPOSITS ON THE PED. PRECHAMBER AN THE CATHETERS WERE ALSO DETECTED. PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT ALL COMPONENTS ARE PERMEABLE. DURING THE PERMEABILITY TEST BLOODY LIQUID WERE FLUSHED OUT. COMPUTER CONTROLLED TEST: TO INVESTIGATE THE CLAIM OF UNDER-DRAINAGE, THE OPENING PRESSURE IS MEASURED USING A MIETHKE COMPUTER CONTROLLED TESTING APPARATUS WHICH SIMULATES A CEREBROSPINAL FLUID FLOW. THE RESULTS SHOW THAT THE SHUNTASSISTANT OPERATES WITHIN THE ACCEPTED TOLERANCE IN THE VERTICAL POSITIONS. ADJUSTMENT TEST: THE PRESSURE STAGES ON THE PROGAV® COULD BE ADJUSTED WITHOUT ANY FORCE BECAUSE THE BRAKE WAS DEFECTIVE. (S. CHAPTER 2.8). BRAKING FORCE AND BRAKE FUNCTION TEST: THE BRAKE FUNCTIONALITY TEST HAS SHOWN THAT THE FUNCTION OF THE BRAKE COULD NOT BE VERIFIED FOR THE PROGAV. THUS, THE BRAKING FORCE COULD NOT BE MEASURED EITHER. INTERNAL INSPECTION: AFTER DISMANTLING OF THE VALVES, DEPOSITS WERE FOUND IN THE SHUNTASSISTANT. TO MAKE THE PROTEINS / DEPOSITS IN THE SHUNT SYSTEM MORE VISIBLE, THEY WERE COLORED USING A STAINING SOLUTION. RESULTS: BASED ON OUR INVESTIGATION RESULTS, WE CAN DETERMINE A DEFORMATION OF THE HOUSING MEMBRANE AND A DAMAGED BRAKE ON THE PROGAV AS WELL AS DEPOSITS IN THE SHUNTASSISTANT AT THE TIME OF OUR INVESTIGATION. THE CAUSE OF THE DAMAGED BRAKE COULD BE THE DETECTED DEFORMATION. EXCESSIVE PRESSURE EXERTED, E.G. BY THE ADJUSTMENT INSTRUMENT OR A FALL OR BLOW TO THE PATIENT'S HEAD, COULD HAVE TRIGGERED THE DEFORMATION OF THE PROGAV. THE DEPOSITS FOUND IN THE SHUNTASSISTANT HAVE NO INFLUENCE ON THE FUNCTIONALITY OF THE VALVE. 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. NO FURTHER REGULATORY ACTIONS ARE REQUIRED FROM OUR POINT OF VIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROGAV SHUNTSYSTEM (#FV441T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN UNDER-DRAINAGE, SPONTANEOUS ADJUSTMENT. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 9 YEARS. WEIGHT: 24 KILOGRAMS (KG) . HEIGHT: 129 CENTIMETERS (CM). GENDER: MALE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595303 PROGAV SYS PED.W/SA 20 A.PRECHAMBER HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FV441T 20021967 04041906132545

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male Required Intervention