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 Codes	Obstruction of Flow (2423); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection during the investigation, scratches on the outer housing of the m.Blue and cuts in the membrane of the ped.Sprung reservoir , were determined.Permeability test a permeability test has shown that all components are permeable.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.The results show that the m.Blue operates within the accepted tolerance in both positions.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 of the m.Blue was detected.The visible deposits led to theaforementioned functional deviation.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.Furthermore, we can determine a visible cut in the membrane of the pediatric sprung reservoir.This had no effect upon the specifications at the time of the examination.The reservoir operated within all specifications.The investigation of the peritoneal catheter revealed no deviations or abnormalities.The product operated within all specifications.The examination of the return has been completed with the drafting of this report.
Event or Problem Description
It was reported that an m.Blue shuntsystem (#fx827t) was implanted on (b)(6) 2025.According to the complainant, the shunt system possibly caused an underdrainage.The patient underwent a revision procedure on (b)(6) 2026.

• 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: 25594425
• Report Number: 3004721439-2026-00171
• Device Sequence Number: 17504107
• Product Code: JXG
• UDI-Device Identifier: 04041906504618
• UDI-Public: (01)04041906504618(11)250722(17)300714(10)20084211
• 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): 06/23/2026

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 Expiration Date: 07/22/2025
• Device Model Number: FX827T
• Device Catalogue Number: FX827T
• Device Lot Number: 20084211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 85 KG