MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 2.0 30; HYDROCEPHALUS MANAGEMENT

Model Number	FX644T
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 progav 2.0 were determined.Permeability test: a permeability test has shown that the valve is 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 valve is tested in the horizontal position.The results show that the valve is not operating within the acceptable tolerance in the horizontal position.An accelerated outflow could be derterminde 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 is fully operational and the braking force is within the given tolerances.Internal inspection: after dismantling of the progav 2.0, deposits were found inside.Result: based on our investigation results, we can determine that there is accelerated drainage at the progav 2.0.The deposits visible in the valve have led to 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.The examination of the return shipment is complete with the preparation of this report.We can exclude a defect at the time of release.The valve 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 shuntsystem (#fx644t) was implanted during a procedure performed on an unspecified date.According to the complainant, the shunt system caused an overdrainage.The patient underwent a revision procedure on an unspecified date.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 30
• 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: 23802477
• Report Number: 3004721439-2025-00675
• Device Sequence Number: 9389851
• Product Code: JXG
• UDI-Device Identifier: 04041906502027
• UDI-Public: (01)04041906502027(11)240710(17)290708(10)20076417
• 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): 12/15/2025

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
• Operator of Device: Health Professional
• Device Model Number: FX644T
• Device Catalogue Number: FX644T
• Device Lot Number: 20076417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2024
• 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: 20 KG