MAUDE Adverse Event Report: Christoph Miethke GmbH & Co KG M.BLUE PLUS SHUNT SYSTEM; HYDROCEPHALUS MANAGEMENT

Model Number	FX814T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an m.Blue shuntsystem (#fx816t) was implanted on (b)(6) 2024.According to the complainant, the shunt system caused an underdrainage.The patient underwent a revision procedure on (b)(6) 2026.
Additional Manufacturer Narrative
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 adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Internal inspection: after dismantling of the valve, no organic deposits were found.Results: based on the investigation results, no functional deviations or other abnormalities were found in the product.The valve is operating within specifications.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 PLUS SHUNT SYSTEM
• 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: 50751989
• Report Number: 3004721439-2026-00266
• Device Sequence Number: 9414752
• Product Code: JXG
• UDI-Device Identifier: 04041906504724
• UDI-Public: (01)04041906504724(11)240614(17)290606(10)20075928
• 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: 2024
• 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): 09/14/2026

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 Model Number: FX814T
• Device Catalogue Number: FX814T
• Device Lot Number: 20075928
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 187 LB