MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA2.0 20 AND SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX385T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: a recording of the manufacturing batch has been completed.No irregularities were found.As soon as the sample is available, the investigation will be completed and a supplementary medwatch report will be submitted.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx385t) was implanted.According to the complainant, the progav 2.0 valve had unintended shunt adjustment.4 years ago, the patient have a previously self- adjusted valve, too.The neurosurgeon suspected that the patient adjusted the shunt himself.The patient underwent a revision procedure and a new single pressure valve was implanted.The shunt is still in transit to manufacturer for examination.
Event or Problem Description
The sample was recieved by the manufacturer and the investigation has been completed.
Additional Manufacturer Narrative
Visual inspection during the investigation, no significant deformations or damage of the valve were determined.Permeability test a permeability test has shown that all components are permeable.Computer controlled test to investigate, 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 the progav 2.0.Results based on our investigation results, we can determine visible deposits in the progav 2.0.The deposits had no effect upon the specifications at the time of the examination.Furthermore, we cannot determine functional deviations or other abnormalities in the shuntassistant 2.0.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.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 WITH SA2.0 20 AND SPRUNG 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: 25505506
• Report Number: 3004721439-2026-00166
• Device Sequence Number: 10539034
• Product Code: JXG
• UDI-Device Identifier: 04041906502461
• UDI-Public: (01)04041906502461(11)260116(17)310115(10)20087665
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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): 06/29/2026

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
• Operator of Device: Health Professional
• Device Model Number: FX385T
• Device Catalogue Number: FX385T
• Device Lot Number: 20087665
• 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: 05/22/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2026
• 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: 13 YR
• Patient Sex: Unknown