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

Model Number	FV414T
Medical Device Problem Codes	Infusion or Flow Problem (2964); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: during the investigation, a deformation of the outer housing of the progav could be determined.The measurement of the plane parallelism could confirm that with a value of -0,080x mm - outside tolerance (0 ± 0.02 mm).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 do not operate within the permissible tolerance in their respective relevant positions.An accelerated outflow of both valves could be determined.Adjustment test: the progav 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 accelerated outflow and non-adjustability on the progav.The deposits visible in the valve and the deformation have led to functional impairments.Furthermore, we can determine accelerated outflow on the shuntassistant in the vertical position.Here too, the deposits found are the cause.Deposits caused by natural substances found 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 impair the integrity of the valve.The investigation of the return shipment is complete with the preparation of this report.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 that a progav shuntsystem (#fv414t) was implanted during a procedure.According to the complainant, the shunt system caused an overdrainage and had adjustment difficulties.The patient underwent a revision procedure on (b)(6) 2025.The complained product was sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.

• Brand Name: PROGAV WITH SHUNTASSISTANT 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: 21942043
• Report Number: 3004721439-2025-00129
• Device Sequence Number: 8799734
• Product Code: JXG
• UDI-Device Identifier: 04041906132118
• UDI-Public: 4041906132118
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 05/01/2025

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
• Operator of Device: Health Professional
• Device Model Number: FV414T
• Device Catalogue Number: FV414T
• Device Lot Number: 20058143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• 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: 7 YR
• Patient Sex: Female
• Patient Weight: 30 KG