MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 5 SYS W/PED.BURRHOLE RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX846T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an m.Blue valve (#fx846t) was implanted during a procedure performed on (b)(6) 2025.According to the complainant, the valve caused an over-drainage.The patient underwent a revision procedure on (b)(6) 2026.No patient complications were reported as a result of the revision procedure.The complained product was sent to the manufacturer for investigation.
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 the 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 valve istested 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, deposits were found in m.Blue.Results based on our investigation results, we can determine visible deposits in the m.Blue.The deposits did not affect the technical properties at the time of the investigation.At the time of the examination, we were unable to determine how the aforementioned functional impairment occurred.Organic material in the patient's own cerebrospinal fluid may have temporarily affected the function and is a known side effect of hydrocephalus therapy.Not every deposit in a shunt system, depending on its location, quantity, and consistency, leads to a deterioration in properties.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.

• Brand Name: M.BLUE 5 SYS W/PED.BURRHOLE 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: 24604172
• Report Number: 3004721439-2026-00062
• Device Sequence Number: 8895185
• Product Code: JXG
• UDI-Device Identifier: 04041906504762
• UDI-Public: (01)04041906504762(11)250822(17)300730(10)20084901
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 03/16/2026

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: FX846T
• Device Catalogue Number: FX846T
• Device Lot Number: 20084901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2025
• 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: 9 MO
• Patient Sex: Male