MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS PED.W/SA20 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FX441T
Medical Device Problem Codes	Obstruction of Flow (2423); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/19/2025
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
Complaint: initial placement: on (b)(6) 2025 and revision surgery was carrid out on (b)(6) 2025.Since it was under-drainage, the doctor attempted to change the valve opening pressure, but was unable to do so.Because there was a suspected valve blockage, a revision surgery was performed.However, during surgery, when checked with the checkmate device, it was confirmed that the pressure could be adjusted.Nevertheless, since the valve was removed, a product investigation request was made.No patient complications were reported as a result of the revision procedure.The complained product was not yet sent to the manufacturer for investigation.
Additional Manufacturer Narrative
Visual inspection: during the investigation, scratches on the outer housing of the progav 2.0 were determined.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 valves are tested in both the horizontal as well as the vertical positions.The results show that the valves operate within the permissible tolerance in their respective relevant positions.Adjustment test: the progav 2.0 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 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 and the ped.Prechamber.Results: based on our investigation results, we can determine visible deposits in all components.The deposits had no effect upon the specifications at the time of the examination.All products operated within the specifications.At the time of the investigation, we were unable to determine how the aforementioned functional impairment occurred.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.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.
Event or Problem Description
The complained product was now sent to the manufacturer for investigation.

• Brand Name: PROGAV 2.0 SYS PED.W/SA20 A.PRECHAMBER
• 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: 24035875
• Report Number: 3004721439-2026-00001
• Device Sequence Number: 15722064
• Product Code: JXG
• UDI-Device Identifier: 04041906137465
• UDI-Public: (01)04041906137465(17)251123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• 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): 02/10/2026

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
• Device Expiration Date: 11/23/2025
• Device Model Number: FX441T
• Device Catalogue Number: FX441T
• Device Lot Number: 20050649
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2020
• 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: 6 YR
• Patient Sex: Male
• Patient Weight: 18 KG