MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 20; HYDROCEPHALUS MANAGEMENT

Model Number	FX413T
Medical Device Problem Codes	Infusion or Flow Problem (2964); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the investigation results, a non-adjustability of the progav 2.0 and an accelerated outflow of both, the progav 2.0 and the shuntassistant, were detected.The visible deposits have led to the functional deviations.Furthermore, we can determine visible bloody deposits in the pediatric control reservoir.The deposits had no effect upon the specifications at the time of the examination.The reservoir operated within all specifications.Deposits caused by substances naturally present in the patient's body, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of organic material can affect the integrity of the valve.In addition to our products, this return shipment also included a peritoneal catheter and a ventricular catheter that were not produced by us.These products were also examined and evaluated in order to complete the investigation.Based on the investigation results, we were able to confirm that the peritoneal catheter had no functional impairment.The ventricular catheter was no longer permeable at the time of the examination.The blood clots within led to the functional impairment.The examination of the return has been completed with the drafting of this report.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx413t) was implanted during a procedure performed on (b)(6) 2020.According to the complainant, the shunt system caused an overdrainage and had adjustment difficulties.The patient underwent a revision procedure on (b)(6) 2025.No patient complications were reported as a result of the revision procedure.The complained device was returned to the manufacturer for evaluation.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 20
• 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: 22478282
• Report Number: 3004721439-2025-00197
• Device Sequence Number: 18188824
• Product Code: JXG
• UDI-Device Identifier: 04041906136550
• UDI-Public: 4041906136550
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• 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): 07/11/2025

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
• Device Model Number: FX413T
• Device Catalogue Number: FX413T
• Device Lot Number: 20070418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2023
• 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 Age: 17 YR
• Patient Sex: Female
• Patient Weight: 95 KG