MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 5 VALVE; HYDROCEPHALUS MANAGEMENT

Model Number	FX801T
Medical Device Problem Codes	Infusion or Flow Problem (2964); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an m.Blue (#fx801t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the shunt system caused an overdrainage and had adjustment difficulties.The patient underwent a revision procedure on (b)(6) 2025.No patient complications were reported as a result of the revision procedure.The complained device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Visual inspection: during the investigation, scratches on the outer housing of the valves , but no significant deformations or damage was determined.Permeability test: a permeability test has shown that all components are 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 is tested in vertical/ or both the horizontal as well as the vertical positions.The results show that the m.Blue is not operating within the acceptable tolerance in either position.An slower outflow could be determined.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, deposits were found.Results: based on our investigation results, we can determine a slower outflow and adjustment difficulties.The determined deposits can be named as the cause for the functional deviation.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.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 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: 21398193
• Report Number: 3004721439-2025-00034
• Device Sequence Number: 18441491
• Product Code: JXG
• UDI-Device Identifier: 04041906504403
• UDI-Public: 4041906504403
• 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: 2022
• 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): 02/17/2025

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 Expiration Date: 02/07/2026
• Device Model Number: FX801T
• Device Catalogue Number: FX801T
• Device Lot Number: 20051695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2021
• 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: 4 YR
• Patient Sex: Female
• Patient Weight: 9 KG