MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYSTEM SA2.0 20 & PED.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FX596T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: no abnormalities were determined.Permeability test: shunt system initially not permeable.After the separation of the components, all components were permeable.Results: based on the investigation results the cause of the reported blockage remains unclear.Maybe rest of the mentioned test fluid saline in the peritoneal catheter caused a temporary blockage.All quality checks during manufacturing and final release control have been passed.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.
Event or Problem Description
It was reported, that a progav 2.0 shunt system (#fx596t) prior to implantation into the patient, no saline flowed out during the shunt drainage test.The catheter is suspected to be blocked.No patient complications were reported as a result of the delayed procedure.The complained product was sent to the manufacturer for investigation.

• Brand Name: PROGAV 2.0 SYSTEM SA2.0 20 & PED.PRECHAMBER
• 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: 22629092
• Report Number: 3004721439-2025-00212
• Device Sequence Number: 15744808
• Product Code: JXG
• UDI-Device Identifier: 04041906503536
• UDI-Public: 4041906503536
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K190174
• 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): 07/28/2025

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: FX596T
• Device Catalogue Number: FX596T
• Device Lot Number: 20080911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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