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

Model Number	FX809T
Medical Device Problem Codes	Infusion or Flow Problem (2964); Insufficient Device Problem Information (3190); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an m.Blue was implanted.According to the complainant, the valve was not in order.The patient underwent a revision procedure.The complained product was not yet sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Manufacturing site evaluation: no product received to date.Should relevant additional information/investigation results become available, an additional medwatch report will be submitted.
Additional Manufacturer Narrative
Visual inspection: during the investigation, blood, deposits and 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 over-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, organic deposits were found in both valves.Results : based on our investigation results, we can determine visible deposits in both valves.The deposits had no effect upon the specifications at the time of the examination.The shuntsystem operated within all specifications.Organic material in the csf can temporarily influence the function and are known side effects in hydrocephalus therapy.The examination of the return has been completed with the drafting of this report.
Event or Problem Description
It was reported that an m.Blue plus valve (fx809t) was implanted on (b)(6)2020.According to the complainant, the valve caused an overdrainage and had adjustement difficulties.The patient underwent a revision procedure on (b)(6)2024.No patient complications were reported as a result of the revision procedure.The sample has been sent to the manufacturer and was investigated.

• Brand Name: M.BLUE PLUS VALVE W/PERITONEAL CATHETER
• 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: 20877593
• Report Number: 3004721439-2024-00373
• Device Sequence Number: 20784615
• Product Code: JXG
• UDI-Device Identifier: 04041906504809
• UDI-Public: 4041906504809
• 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: 2020
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 03/03/2025

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: 10/29/2025
• Device Model Number: FX809T
• Device Catalogue Number: FX809T
• Device Lot Number: 20050385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2020
• 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: 35 YR
• Patient Sex: Female
• Patient Weight: 65 KG