MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 W/SA2.0 20 & PED.CONTROL RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FX673T
Medical Device Problem Codes	Infusion or Flow Problem (2964); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection during the investigation, calcification on the devices were determined.Permeability test a permeability test has shown that all components 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 positions.The results show that the progav 2.0 does not operate within the accepted tolerance in the horizontal position.The shuntassistant 2.0 operates within the specified tolerances in the vertical position.An accelerated outflow of progav 2.0 was determined.Adjustment test the progav 2.0 was tested and is not adjustable.Braking force and brake function test the brake functionality test has shown that the brake function operates as expected.However, the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection after dismantling of the valves, deposits were found inside the progav 2.0 and the ped.Control reservoir.Results based on the investigation results, an accelerated outflow and a non-adjustable progav 2.0 were determined.The deposits visible in the valve led to the aforementioned functional impairments.During the investigation of the shuntassistant 2.0, no functional deviations or other abnormalities were found.The valve is operating within specifications.Deposits were detected during the examination of the pediatric control reservor.These deposits did not affect the device's technical specifications at the time of the investigation.Deposits caused by substances naturally present in the 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 deposits can compromise the integrity of the valve.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.
Event or Problem Description
It was reported that a progav 2.0 shunt system(#fx673t) was implanted.According to the complainant, the shunt system caused an over-drainage and had adjustment difficulties.The patient underwent a revision procedure on (b)(6) 2026.No patient complications were reported as a result of the revision procedure.

• Brand Name: PROGAV 2.0 W/SA2.0 20 & PED.CONTROL RES.
• 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: 25716414
• Report Number: 3004721439-2026-00182
• Device Sequence Number: 5141709
• Product Code: JXG
• UDI-Device Identifier: 04041906502270
• UDI-Public: (01)04041906502270(11)230925(17)280921(10)20071501
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 07/06/2026

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: FX673T
• Device Catalogue Number: FX673T
• Device Lot Number: 20071501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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: 3 YR
• Patient Sex: Female
• Patient Weight: 12 KG