MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	FX800T
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a m.Blue 0 valve (part # fx800t) was implanted on an unspecified date.According to the complainant, the device was explanted on (b)(6) 2025 for an unspecified reason.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.Additional information has been requested but not yet received.
Additional Manufacturer Narrative
The adverse event is filed under aic reference xc (b)(4).Cc (b)(4).Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Additional information: a2 patient age.A3a patient gender.B7 relevant history.D6a and d6b implant and explant dates.Visual inspection: during the investigation, no significant deformations or damage of the valves was 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 valve is operating not within the accepted tolerance in the vertical position.An accelerated outflow of m.Blue 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 funciton is given.Internal inspection: after dismantling of the valve, deposits were found.Results: according to the investigation results, a non-adjustability and an accelerated outflow of the m.Blue were detected.The visible deposits led to the functional deviations.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.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
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ,; GM 14469,
• MDR Report Key: 24165250
• Report Number: 2916714-2026-00001
• Device Sequence Number: 18420188
• Product Code: JXG
• UDI-Device Identifier: 04041906504397
• UDI-Public: (01)04041906504397(17)250621(10)20048452
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026
• Report Date (Section F): 01/23/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2025
• Device Model Number: FX800T
• Device Catalogue Number: FX800T
• Device Lot Number: 20048452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/14/2026
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 01/30/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/23/2026