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	Cyst(s) (1800)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, bloody tissue residues on the shunt were determined.Permeability test: the permeability test showed that the m.Blue is occluded.The progav 2.0 and the pre-chamber are permeable.Computer control test: due to the determined blockage of the m.Blue, the test is not applicable.The testing of the progav 2.0 revealed that the valve operates within the specification.Adjustability test: both valves are not adjustable.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected.However, the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection: after dismantling of the valves, organic deposits were found in both valves.Summary: according to the investigation results, the m.Blue was found to be non-adjustable and blocked.The visible deposits led to these functional deviations.In addition, the progav 2.0 was also no longer adjustable.The functional deviation was also caused by the visible deposits inside.In the pediatric pre-chamber, organic deposits were also visible.At the time of the investigation, the deposits had no affect to the specifications.The product 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.
Event or Problem Description
It was reported that a m.Blue plus (#fx804t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, th eshunt system caused an under drainage.The patient underwent a revision procedure on (b)(6) 2025.The complained product was returned for examination to the manufacturer.No patient complications were reported as a result of the revision procedure.

• 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: 22308938
• Report Number: 3004721439-2025-00160
• Device Sequence Number: 7997345
• Product Code: JXG
• UDI-Device Identifier: 04041906504793
• UDI-Public: 4041906504793
• 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: 2023
• 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): 06/23/2025

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: 20071907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• 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: 24 MO
• Patient Sex: Male
• Patient Weight: 15 KG