MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 25 & PED.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FX597T
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation investigation on-going.Should relevant additional information or the investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx597t) was implanted during a procedure performed on (b)(6) 2024.According to the complainant, the shunt system caused an overdrainage.The patient underwent a revision procedure on (b)(6) 2025.No patient complications were reported as a result of the revision procedure.The complained device was returned to the manufacturer for evaluation.
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 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 progav 2.0 operates within the accepted tolerance in the horizontal position.The shuntassistant 2.0 does not operate within the specified tolerances in the vertical position.An accelerated outflow of shuntassistant 2.0 could be 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 breaking force cannot be measured due to the non-adjustability of the valve.Internal inspection: after dismantling of the valves, deposits were found in both valves.Results: based on our investigation results, we can determine an accelerated outflow in the shuntassistant 2.0 and adjustment difficulties in the progav 2.0.The determined deposits can be named as the cause for the functional deviations.Furthermore, we can determine deposits in the pediatric prechamber.The deposits had no affect to the technical properties at the time of the investigation.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.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 device was returned to the manufacturer for evaluation and the investigation has been completed.

• Brand Name: PROGAV 2.0 SYS SA2.0 25 & 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: 22827073
• Report Number: 3004721439-2025-00230
• Device Sequence Number: 11900487
• Product Code: JXG
• UDI-Device Identifier: 04041906503543
• UDI-Public: 4041906503543
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/15/2025

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 Model Number: FX597T
• Device Catalogue Number: FX597T
• Device Lot Number: 20070755
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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: 4 YR
• Patient Sex: Female
• Patient Weight: 13 KG