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	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 shunt system (#fx597t) was implanted on (b)(6) 2026.According to the complainant, the procedure caused an infection.The patient underwent a revision procedure on (b)(6) 2026.No patient complications were reported as a result of the revision procedure.
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 determine the opening pressure of the valve a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow is used.The valve is 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.Results based on the product data traceability, no deviations in manufacturing or sterilization were identified.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 examination of the progav 2.0 and the shuntassistant 2.0, visible organic deposits were found inside the devices.These deposits did not affect the technical properties at the time of the examination.No further regulatory actions are required from our point of view.

• 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: 50038581
• Report Number: 3004721439-2026-00202
• Device Sequence Number: 13217878
• Product Code: JXG
• UDI-Device Identifier: 04041906503543
• UDI-Public: (01)04041906503543(11)250206(17)300202(10)20080470
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 07/27/2026

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: FX597T
• Device Catalogue Number: FX597T
• Device Lot Number: 20080470
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2026
• 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: 27 YR
• Patient Sex: Female
• Patient Weight: 140 LB