MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG DUALSWITCH-VALVE 10/30; HYDROCEPHALUS MANAGEMENT

Model Number	FV100T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/12/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that a dsv valve (#fv119t) was implanted on (b)(6) 2025.According to the complainant, the valve caused an overdrainage.The patient underwent a revision procedure on (b)(6) 2025.No patient complications were reported as a result of the revision procedure.The complained product was not yet sent to the manufacturer for investigation.
Event or Problem Description
It was reported that a dsv valve (#fv100t) was implanted on (b)(6) 2025.The complained product was now sent to the manufacturer for investigation.
Additional Manufacturer Narrative
Visual inspection during the investigation, no significant deformations or damage of the valves were determined.Permeability test, a permeability test has shown that the valve is 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 positions.The results show that dsv operates not within the permissible tolerance in the horizontal position but in the vertical position.An slower outflow of the dsv in the horizontal position could be determined.Internal inspection: after dismantling of the valve, deposits were found in the dsv.Results: according to the results of the investigation, a reduced outflow in the horizontal position of the dsv was detected.The visible deposits led to the functional deviation.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: DUALSWITCH-VALVE 10/30
• 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: 23726572
• Report Number: 3004721439-2025-00397
• Device Sequence Number: 13424286
• Product Code: JXG
• UDI-Device Identifier: 04041906101008
• UDI-Public: (01)04041906101008(11)250515(17)300514(10)20082772
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: FV100T
• Device Catalogue Number: FV100T
• Device Lot Number: 20082772
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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: 20 YR
• Patient Sex: Male
• Patient Weight: 88 KG