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

Model Number	FV251T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: the traceability of the production did not reveal any unusual findings.The shunt system met all specifications before shipment.Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a shuntassistant (#fv251t) was implanted together with a progav 2.0 shuntsystem (fx#431-t) during a procedure on (b)(6) 2024.Some adjustments of the progav 2.0 were performed.On (b)(6) 2025 the patient came in the hospital for review and needed an adjustment.The change of the pressure setting was not possible.Therefore, the patient underwent a revision procedure on (b)(6) 2025 of both products.The revised products were sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.Same event as medwatch 3004721439-2025-00262 (#fx431-t).
Additional Manufacturer Narrative
Manufacturing site evaluation: visual inspection during the investigation, no significant deformations or damage of the valves was determined.Permeability test a permeability test has shown that the shuntassistant is permeable.Computer controlled test to measure the opening pressure using a computer-controlled miethke testing device that simulates the flow of cerebrospinal fluid, the valve is tested in horizontal and vertical positions.The results show that the valve operates within the accepted tolerance in both positions.Internal inspection after dismantling of the valve, no deposits were found inside results based on our investigation results, we cannot determine any functional deviations or other abnormalities in the shuntassistant.The product operated within all specifications.The examination of the return has been completed with the drafting of this report.No further actions are required as a result of the complaint.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: 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: 22976818
• Report Number: 3004721439-2025-00261
• Device Sequence Number: 15682971
• Product Code: JXG
• UDI-Device Identifier: 04041906136628
• UDI-Public: 4041906136628
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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
• Operator of Device: Health Professional
• Device Model Number: FV251T
• Device Catalogue Number: FV251T
• Device Lot Number: 20081003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2025
• 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 Age: 10 YR
• Patient Sex: Female