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

Model Number	FX424T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Summary of the investigation results: based on our investigation results, the ventricular catheter was returned in two parts and showed signs of cuts and cracks that were not caused by the manufacturing process.We are unable to explain how the above-mentioned damage occurred.The irregular separation indicates that the catheter has come into contact with a sharp object.Testing procedures with catheters under tension to the point of tearing shows only a raw and uneven surface (no.2).Quality assurance is performed before each shipment of products.In general, all catheters undergo a tensile test and a visual inspection.All tests are documented in an acceptance report.The returned product has successfully passed all tests.Therefore, the presence of a defect at the time of delivery can be excluded.We would also like to draw your attention once again to the "safety measures and contraindications" section of the ifu sent with the product, where it is pointed out that caution should be exercised when using sharp devices while handling the catheters.The examination of the return has been completed with the drafting of this report.
Event or Problem Description
It was reported that a vetricular catheter part of a progav 2.0 shunt system (#fx424t) tore during pre-surgery preparations.No patient involvement.

• Brand Name: PROGAV 2.0 SYSTEM WITH SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam 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: 25070709
• Report Number: 3004721439-2026-00119
• Device Sequence Number: 10415277
• Product Code: JXG
• UDI-Device Identifier: 04041906136949
• UDI-Public: (01)04041906136949(11)251114(17)301110(10)20086585
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: FX424T
• Device Catalogue Number: FX424T
• Device Lot Number: 20086585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2025
• 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