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	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an m.Blue shuntsystem (#fx827t) was implanted.According to the complainant, the shunt system caused a malfunction.The patient underwent a revision procedure.
Additional Manufacturer Narrative
Visual inspection during the investigation, no significant deformations or damage of the valves was determined.Permeability test a permeability test has indicated that the m.Blue has a blockage.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 valve is tested in vertical/ or both the horizontal as well as the vertical positions.Because the valve is not permeable, a computer controlled test is not applicable.Adjustment test the m.Blue valve was tested and is not adjustable throughout the normal range.Braking force and brake function test the brake functionality test has shown that the brake function is operational.However, the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection after dismantling of the valve, organic deposits were found.Results according to the investigation results, a non-adjustability and a blockage of the m.Blue were detected.The visible deposits led to the visible deposits led to the aforementioned functional impairments.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.

• 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: 50275055
• Report Number: 3004721439-2026-00235
• Device Sequence Number: 10578139
• Product Code: JXG
• UDI-Device Identifier: 04041906504618
• UDI-Public: (01)04041906504618(11)250611(17)300603(10)20083362
• 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: 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): 08/17/2026

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: FX827T
• Device Catalogue Number: FX827T
• Device Lot Number: 20083362
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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 Sex: Unknown