MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 2.0 25; HYDROCEPHALUS MANAGEMENT

Model Number	FX643T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
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 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 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 progav 2.0.Results: based on the investigation results, no functional abnormalities were detected in the shuntassistant 2.0.Visible deposits were found in the progav 2.0; however, these did not affect the technical properties at the time of the investigation.At the time of the examination, it was not clear to us how the aforementioned functional impairment occurred.Organic material in the patient's own cerebrospinal fluid may have temporarily affected function and is a known side effect of hydrocephalus therapy.Not every deposit in a shunt system depending on its location, quantity, and consistency leads to a deterioration in performance.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
It was reported tha a progav 2.0 with a shuntassistant 2.0 (25) (#fx643t) were implanted during a procedure performed.According to the complainant, the shunt system caused an overdrainage.The patient underwent a revision procedure.No patient complications were reported as a result of the revision procedure.The complained device was returned to the manufacturer for evaluation.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 2.0 25
• 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: 24927996
• Report Number: 3004721439-2026-00104
• Device Sequence Number: 20128769
• Product Code: JXG
• UDI-Device Identifier: 04041906502010
• UDI-Public: (01)04041906502010(11)240606(17)290604(10)20075746
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/20/2026

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: FX643T
• Device Catalogue Number: FX643T
• Device Lot Number: 20075746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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: 18 KG