MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYSTEM SA2.0 15 AND CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX550T
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a progav 2.0 (#fx550t) was was unable to program prior use.The incident contribute a delay of the surgery (5 minutes).No patient complications were reported.The complained product will be sent to the manufacturer for investigation.
Additional Manufacturer Narrative
Visual inspection during the investigation, no significant deformations or damage of the valve were determined.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.Results based on our investigation results, we cannot determine any problems with the adjustment or other deviations of the valve.The fact that the valve is set to 0 cmh2o proves that the valve must have been adjustable.The opening pressure on delivery was set to 5 cmh2o.In accordance to the documentation, the quality assurance department can rule out a defect before delivery.The examination of the return has been completed with the drafting of this report.Actions no further actions are required as a result of the complaint.We can exclude a defect at the time of release.The shunt system 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
The complained product is now sent to the manufacturer for investigation.

• Brand Name: PROGAV 2.0 SYSTEM SA2.0 15 AND 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: 23463428
• Report Number: 3004721439-2025-00328
• Device Sequence Number: 9084933
• Product Code: JXG
• UDI-Device Identifier: 04041906503154
• UDI-Public: (01)04041906503154(11)250610(17)300604(10)20083338
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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 Expiration Date: 06/04/2023
• Device Model Number: FX550T
• Device Catalogue Number: FX550T
• Device Lot Number: 20083338
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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