MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE PLUS SYS W/CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX824T
Medical Device Problem Codes	Infusion or Flow Problem (2964); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an m.Blue plus (#fx824t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the shunt system caused an overdrainage and adjustment difficulties the patient underwent a revision procedure on (b)(6) 2024.No patient complications were reported as a result of the revision procedure.The complained product was sent to the manufacturer for investigation.
Additional Manufacturer Narrative
Visual inspection: during the investigation, scratches on the outer housing of the valves were determined permeability test: a permeability test has shown that both componets 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 operate within the permissible tolerance in their respective relevant position.Adjustment test: during the adjustment test it was determined that both valves are adjustable in all pressure ranges.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 tolerances.Internal inspection: after dismantling of the valves, deposits were found in both valves.Results: based on our investigation results, we can see visible deposits in the m.Blue and in the progav 2.0.The deposits did not affect the technical properties at the time of the investigation.The examination of the control reservoir showed no deviations; it met the specifications.At the time of the examination, it was not possible for us to determine how the functional impairment mentioned above occurred.Proteins in the cerebrospinal fluid can temporarily affect its function and are known side effects of hydrocephalus therapy.We can exclude a defect at the time of release.The shunt system 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 SYS W/CONTROL RESERVOIR
• 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: 20878001
• Report Number: 3004721439-2024-00386
• Device Sequence Number: 13004813
• Product Code: JXG
• UDI-Device Identifier: 04041906504830
• UDI-Public: 4041906504830
• 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: 2023
• 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
• Report Date (Section B): 12/09/2024

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: FX824T
• Device Catalogue Number: FX824T
• Device Lot Number: 20061690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 70 KG