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

Model Number	FX804T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a m.Blue plus (# fx804t) was implanted during a procedure on (b)(6) 2025.According to the complainant, the valve caused an underdrainage.The patient underwent a revision procedure on (b)(6) 2025.The complained product was sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Visual inspection: during the investigation, tissue residues on the devices 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 results show that the valves are operating within the specified tolerances in their respective relevant position.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, no organic deposits were found in both valves.Results: based on our investigation results, we cannot determine any functional deviations or other abnormalities in the m.Blue or the progav 2.0.The products operated within all specifications.How the abovementioned functional impairment occurred is not clear to us at the time of examination.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 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: 23451863
• Report Number: 3004721439-2025-00321
• Device Sequence Number: 9174479
• Product Code: JXG
• UDI-Device Identifier: 04041906504793
• UDI-Public: (01)04041906504793(11)250714(17)300713(10)20084069
• 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: 2025
• 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): 12/12/2025

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: FX804T
• Device Catalogue Number: FX804T
• Device Lot Number: 20084069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2025
• 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: 30 YR
• Patient Sex: Male
• Patient Weight: 88 KG