MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 0 VALVE; HYDROCEPHALUS MANAGEMENT

Model Number	FX800T
Medical Device Problem Codes	Infusion or Flow Problem (2964); Insufficient Device Problem Information (3190); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx583a) was implanted during a procedure performed on an unspecified date.According to the complainant, the shunt system had a malfunction.The patient underwent a revision procedure on an unspecified date.No patient complications were reported as a result of the revision procedure.The complained device was not yet returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Manufacturing site evaluation: no product received to date.Should relevant additional information/investigation results become available, an additional medwatch report will be submitted.
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 zhe m.Blue is permeable.Computer controlled test: to investigate the claim of over-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical position.The results show that the valve is operating within the specified tolerances in both positions.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, no deposits were found in m.Blue.Results: based on our investigation results, we cannot determine any functional deviations or other abnormalities.The valves operated within all specification.How the abovementioned functional impairment occurred is not clear to us at the time of examination.The examination of the return has been completed with the drafting of this report.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 a m.Blue 0 valve (#fx800t) was implanted during a procedure performed on (b)(6) 2024.According to the complainant, the valve caused an over-drainage and had adjustmen 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 device was now returned to the manufacturer for evaluation.Same event as #3004721439-2025-00361.

• Brand Name: M.BLUE 0 VALVE
• 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: 23451064
• Report Number: 3004721439-2025-00315
• Device Sequence Number: 18402181
• Product Code: JXG
• UDI-Device Identifier: 04041906504397
• UDI-Public: (01)04041906504397(11)240726(17)290724(10)20076758
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: FX800T
• Device Catalogue Number: FX800T
• Device Lot Number: 20076758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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: 15 YR
• Patient Sex: Male
• Patient Weight: 55 KG