MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA20 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX352T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Hydrocephalus (3272); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: no product received to date.Should relevant additional information/investigation results become available, an additional medwatch report will be submitted.
Event or Problem Description
It was reported that a progav 2.0 shunt system (#fx352t) was blocked pre-implantation.No patient involvement.The complained product was not yet sent to the manufacturer for investigation.
Additional Manufacturer Narrative
Investigation: visual inspection: no abnormalities were determined.Permeabilty test: all components were permeable.Adjustabilty test: the progav 2.0 was adjustable to all pressure settings.Brake function: the brake is full in function.Conclusion: based on our investigation results, visible deposits in the sprung reservoir were determined.The deposits had no effect upon the specifications at the time of the examination.The shuntsystem operated within all specifications.
Event or Problem Description
It was reported that a progav 2.0 shunt system ((b)(6)) was blocked pre-implantation.No patient involment.The complained product was return to the manufacturer for investigation on 03/18/2026.

• Brand Name: PROGAV 2.0 WITH SA20 A.SPRUNG RESERVOIR
• 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: 24547109
• Report Number: 3004721439-2026-00065
• Device Sequence Number: 13107949
• Product Code: JXG
• UDI-Device Identifier: 04041906140014
• UDI-Public: (01)04041906140014(11)251016(17)301015(10)20085926
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• 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,Followup
• Report Date (Section B): 04/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FX352T
• Device Catalogue Number: FX352T
• Device Lot Number: 20085926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2025
• 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 Sex: Unknown