MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYSTEM W. SA15 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX434T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx433t) wanted to be implanted.According to the complainant, the shunt system appears to have become blocked during the procedure.As a result, the shunt could not be used, and an additional shunt had to be used to complete the procedure.The event was considered non-serious by the client.Patient recovering.
Additional Manufacturer Narrative
The investigation on-going.Should relevant additional information or the investigation results become available, a supplemental medwatch report will be submitted.

• Brand Name: PROGAV 2.0 SYSTEM W. SA15 A.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: 25260351
• Report Number: 3004721439-2026-00145
• Device Sequence Number: 5495879
• Product Code: JXG
• UDI-Device Identifier: 04041906137328
• UDI-Public: (01)04041906137328(11)251013(17)301001(10)20085798
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K161853
• 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): 07/06/2026

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: FX434T
• Device Catalogue Number: FX434T
• Device Lot Number: 20085798
• 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: 04/28/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2025
• 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: Female