MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 20 & PED.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FX596T
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a progav 2.0 sys sa2.0 20 & ped.Prechamber (#fx596t) was to be implanted on (b)(6) 2025.According to the complainant, the prechamber caused malfunction.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Visual inspection: during the investigation, no significant deformations or damage of the components were determined.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to verify that the valve operates within the specified tolerance range, it is measured using a computer-controlled testing device from miethke that simulates the flow of cerebrospinal fluid.The valves are tested in both horizontal and 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, no deposits were found inside.Results: based on our investigation results, we cannot determine any functional deviations or other abnormalities in all three components.The components operated within all specifications.The examination of the return has been completed with the drafting of this report.A defect at the time of release can be excluded.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: PROGAV 2.0 SYS SA2.0 20 & PED.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: 25001750
• Report Number: 3004721439-2026-00110
• Device Sequence Number: 9756941
• Product Code: JXG
• UDI-Device Identifier: 04041906503536
• UDI-Public: (01)04041906503536(11)250616(17)300611(10)20083464
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FX596T
• Device Catalogue Number: FX596T
• Device Lot Number: 20083464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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 Sex: Unknown