MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYSTEM W. SA2.0 25 AND PED.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX610T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that in one progav 2.0 shuntsystem (#fx610t) it was found that the pressure of the product could not be adjusted during the preparation.No patient harms have been reported in this context.The sample will be send for examination to miethke.
Additional Manufacturer Narrative
Manufacturing site evaluation: the traceability of the production did not reveal any unusual findings.The shunt system met all specifications before shipment.The sample has not yet been sent for examination.Should relevant additional information become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, no abnormalities of the shuntsystem was determined.Adjustment test: the progav 2.0 was tested and is adjustable to all specified pressures.Brake function test: the brake functionality test has shown that the brake function operates as expected.Result: based on our investigation results, we cannot determine functional deviations or other abnormalities in the product.The product operated within all specification.No further regulatory actions are required from our point of view.
Event or Problem Description
It has been reported that the rogav 2.0 shuntsystem (#fx610t) could not be adjusted during the preparation.No patient harms have been reported in this context.The sample was send in for examination to miethke.

• Brand Name: PROGAV 2.0 SYSTEM W. SA2.0 25 AND PED.CONTROL 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: 22478203
• Report Number: 3004721439-2025-00198
• Device Sequence Number: 18128303
• Product Code: JXG
• UDI-Device Identifier: 04041906503741
• UDI-Public: 4041906503741
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 08/04/2025

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: FX610T
• Device Catalogue Number: FX610T
• Device Lot Number: 20079583
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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