MAUDE Adverse Event Report: Christoph Miethke GmbH & Co KG PROGAV 2.0 W/SA2.0 20 & PED.CONTROL RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FX673T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 (#fx673t) was implanted on (b)(6) 2024.According to the complainant, the valve caused an over-drainage.The patient underwent a revision procedure on (b)(6) 2026.No patient complications were reported as a result of the revision procedure.Same event as # (b)(6).
Additional Manufacturer Narrative
Visual inspection during the investigation, scratches on the outer housing 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 operates within the accepted tolerances in the horizontal position.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 valve, no organic deposits were found.Result based on the test results, no functional deviations or other abnormalities were found in the progav 2.0.The valve is operating within its specifications.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.

• Brand Name: PROGAV 2.0 W/SA2.0 20 & PED.CONTROL RES.
• 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: 50038832
• Report Number: 3004721439-2026-00206
• Device Sequence Number: 9946487
• Product Code: JXG
• UDI-Device Identifier: 04041906504397
• UDI-Public: (01)04041906504397(11)241115(17)291114(10)20078817
• 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 Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• 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: FX673T
• Device Catalogue Number: FX673T
• Device Lot Number: 20074427
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/29/2026
• Is the Reporter a Health Professional?: No
• 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: 04/02/2024
• 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: 31 YR
• Patient Sex: Male
• Patient Weight: 127 LB