MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 10 SYS W/PED.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX827T
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: during the investigation, scratches on the outer housing of the valves, were determined.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to determine the opening pressure of the m.Blue a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow is used.The valve is tested in both the horizontal as well as the vertical positions.The results show that the m.Blue is not operating within the acceptable tolerance in either position.An accelerated outflow of m.Blue could be determined.Adjustment test: the m.Blue valve was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Internal inspection: after dismantling of the valve, deposits were found in m.Blue + the rediatric sprung reservoir results: according to the results of the investigation, an accelerated outflow of the progav 2.0 was detected.The visible deposits led to the functional deviation.Furthermore, we can determine visible deposits in the pediatric sprung reservoir.The deposits had no effect upon the specifications at the time of the examination.The reservoir operated within all specifications.Deposits caused by substances naturally present in the patient's body, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of organic material can affect the integrity of the valve.We can exclude a defect at the time of release.The valve 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.
Event or Problem Description
It was reported that an m blue shunt system (#fx827t) was implanted during a procedure performed on (b)(6) 2024.According to the complainant, the shunt system had adjustment difficulties.The patient underwent a revision procedure on (b)(6) 2025.No patient complications were reported as a result of the revision procedure.The complained product was sent to the manufacturer for investigation.

• Brand Name: M.BLUE 10 SYS W/PED.SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 23391289
• Report Number: 3004721439-2025-00310
• Device Sequence Number: 18653771
• Product Code: JXG
• UDI-Device Identifier: 04041906504618
• UDI-Public: 4041906504618
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FX827T
• Device Catalogue Number: FX827T
• Device Lot Number: 20076957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2025
• Initial Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male