MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT (25); HYDROCEPHALUS MANAGEMENT

Model Number	FV252T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shuntassistant (#fv252t) was tested preoperatively and showed unexpected behavior.No patient involvement.The incident was reported to the manufacturer late on november 13, 2024.
Additional Manufacturer Narrative
Manufacturing site evaluation: traceability of production data was performed and showed no deviation.The investigation is on-going.Should the investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, dry cristaline visible deposits in the inlet/outlet spout were determined.Permeability test: a permeability test has shown that the valve is permeable.Computer controlled test: to investigate the claim of made by the customer: "did not resist to scf flow in vertical position - preoperative", the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in both the horizontal as well as the vertical positions.The results show that the valve is not operating within the accepted tolerance in the vertical position.A tendency to an accelerated outflow could be determined.Internal inspection: after dismantling of the valve, no deposits were found.Results: please note - the valve was tested before use with saline solution.After the testing the valve was not inserted in solution and was returned in dry condition with a clear delay.The testing of dry products is of limited value.A dried-up saline solution can lead to invalid test results.Based on our test results, we can determine dry visible deposits in the spouts and a tendency to an accelerated outflow at the valve in vertical position.Opening valves allows a view of a significant part of the interior.Nevertheless, there are areas which evade visual inspection.In these parts, it is also possible to have dry deposits which can influence the function of the valve.The examination of the return product has been completed with the drafting of this report.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.No further regulatory actions are required from our point of view.

• Brand Name: SHUNTASSISTANT (25)
• 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: 20704986
• Report Number: 3004721439-2024-00371
• Device Sequence Number: 13171362
• Product Code: JXG
• UDI-Device Identifier: 04041906113308
• UDI-Public: 4041906113308
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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 Expiration Date: 05/03/2026
• Device Model Number: FV252T
• Device Catalogue Number: FV252T
• Device Lot Number: 20052979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2021
• 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
• Patient Sex: Unknown