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	Material Integrity Problem (2978)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection.Visible cuts and cracks at the ends of the catheter.Summary of the investigation results: based on our investigation results, we can determine that the end peritoneal catheter showed signs of non-production-related cuts and cracks.We are unable to explain how the above-mentioned damage occurred.The irregular cutting edge indicates that the catheter was in contact with a sharp object.Testing procedures with catheters under tension to the point of tearing shows only a raw and uneven surface.Prior all shipments of products with catheters a tension test is performed, which was documented in a final documentation.The returned product passed a successfully test.So, we can exclude the presence of a defect at the time of delivery, since the final documentation proves a successfully completed test.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.
Event or Problem Description
It was reported that a peritoneal catheter from a progav 2.0 shunt system (#fx424t) broke intraoperatively.No patient complications were reported as a result of the revision procedure.The complained product was sent to the manufacturer for investigation.

• 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 ; 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: 24303636
• Report Number: 3004721439-2026-00020
• Device Sequence Number: 9678457
• Product Code: JXG
• UDI-Device Identifier: 04041906136949
• UDI-Public: (01)04041906136949(11)250828(17)300728(10)20085012
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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
• Device Model Number: FX424T
• Device Catalogue Number: FX424T
• Device Lot Number: 20085012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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