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

Model Number	FX804T
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an m.Blue plus (#fx804t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the shunt system caused an overdrainage and 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 device was not yet returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Manufacturing site evaluation investigation on-going.Should relevant additional information or the investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
The complained device was returned to the manufacturer for evaluation.The investigation has been completed.
Additional Manufacturer Narrative
Visual inspection: during the investigation, deposits/ tissue residues on the device were determined permeability test: a permeability test has shown that both valves are 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 result shows that the progav 2.0 operates within the accepted tolerances in the horizontal position.However, the m.Blue does not operate within the specified tolerances in the horizontal position.A slower outflow of m.Blue could be determined.Adjustment test: the valves were tested and both valves are not adjustable in all pressure settings.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected.However, the braking force cannot be measured due to the non-adjustability of the valves.Internal inspection: after dismantling of the valves, organic deposits were found in both valves.Results: according to the investigation results, a reduced outflow of the m.Blue in the horizontal position and a non-adjustability of both valves were detected.The visible deposits have led to the functional deviations.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 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.

• Brand Name: M.BLUE PLUS 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: 22117136
• Report Number: 3004721439-2025-00152
• Device Sequence Number: 4172124
• Product Code: JXG
• UDI-Device Identifier: 04041906504793
• UDI-Public: 4041906504793
• 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: 2023
• 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): 07/21/2025

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
• Device Model Number: FX804T
• Device Catalogue Number: FX804T
• Device Lot Number: 20070962
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 73 KG