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

Model Number	FX819T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an m.Blue plus(#fx819t) was implanted during a procedure performed on (b)(6) 2025.According to the complainant, the shunt system caused an underdrainage.The patient underwent a revision procedure on (b)(6) 2025.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, no significant deformations or damages of the valves were determined.Permeability test: a permeability test has shown that both valves 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 valves are tested in both the horizontal as well as the vertical position.The result shows that the m.Blue operates not within the accepted tolerances in the vertical position.However, the m.Blue and the progav 2.0 operates within the specified tolerances in the horizontal position.An accelerated outflow of m.Blue in the vertical position could be determined.Adjustment test: the valves were tested and both valves are adjustable in all pressure settings.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected and the braking force is within the given tolerance.Internal inspection: after dismantling of the valves, organic deposits were found in both valves and the reservoir.Results: according to the results of the investigation, an accelerated outflow at the m.Blue was detected.The visible deposits led to the functional deviation.Furthermore, we can determine visible deposits in the progav 2.0 and in the pedi.Control reservoir.The deposits had no effect upon the specifications at the time of the examination.The products operated within all specifications.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.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 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 SYS W/PED.CONTROL 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: 23277739
• Report Number: 3004721439-2025-00295
• Device Sequence Number: 5470216
• Product Code: JXG
• UDI-Device Identifier: 04041906504823
• UDI-Public: 4041906504823
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 10/13/2025

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: FX819T
• Device Catalogue Number: FX819T
• Device Lot Number: 20079399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• 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: 11 YR
• Patient Sex: Male
• Patient Weight: 38 KG