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

Model Number	FV414T
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav shunt system (#fv414t) was implanted.According to the complainant, an infection was diagnosed.The patient underwent a revision procedure.No patient complications were reported as a result of the revision procedure.The complained product was sent to the manufacturer for investigation.
Additional Manufacturer Narrative
Visual inspection: during the investigation, scratches on the outer housing of the valves, but no significant deformations or damage 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 progav operates within the accepted tolerance in the horizontal position.The shuntassistant does not operate within the specified tolerances in the vertical position.An accelerated outflow of shuntassistant could be determined.Adjustment test: the progav 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 shuntassistant.Results: a review of the product data revealed no deviations in manufacturing or sterilization.Shunt infections are a common and serious complication of shunt treatment.These can have various causes and are difficult to trace retrospectively.In addition to the traceability review, we examined the returned products for compliance with their specifications.During the investigation of the progav valve, visible organic deposits were detected.These deposits did not affect the technical properties at the time of the investigation.Furthermore, an accelerated flow rate was measured in the shuntassistant.The deposits visible in the valve can be cited as the cause of the change in flow rate.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 compromise the integrity of the valve.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.

• 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: 24927768
• Report Number: 3004721439-2026-00101
• Device Sequence Number: 12057253
• Product Code: JXG
• UDI-Device Identifier: 04041906132118
• UDI-Public: (01)04041906132118(11)251215(17)301211(10)20087177
• 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: 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): 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
• Device Model Number: FV414T
• Device Catalogue Number: FV414T
• Device Lot Number: 20087177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2025
• 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