MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV SYSTEM 4/19 WITH PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FV303T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: 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 problem occurred during the implantation procedure (using # fv303t in combination with # fx431-t).After connecting both products, it was found that the reservoir could not spring back.The products were replaced with new ones and the operation was successfully performed with a delay of 1 hour.The samples will be returned to manufacturer for examniation.Article # fx431-t was reported in medwatch 3004721439-2026-00003.
Additional Manufacturer Narrative
Visual inspection.During the investigation, no significant deformations or damage of the products were determined.Permeability test.A permeability test has shown that all components are permeable.Computer controlled test.To investigate the claim of under-drainage, 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 operates within the accepted tolerance in both positions.Results.In advance, we would like to point out that the product sent in was not inserted in liquid at the time of delivery.Dried deposits can influence the function of the products, which can affect the results.Despite this, we have examined the valve.Based on our investigation results, we cannot determine any functional deviations or other abnormalities in both products.The products operated within all specifications.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from (b)(4).No further regulatory actions are required from our point of view.
Event or Problem Description
The samples was now returned to manufacturer for examination.Article # (b)(4) was reported in medwatch 3004721439-2026-00003.

• Brand Name: PAEDIGAV SYSTEM 4/19 WITH 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: 24114711
• Report Number: 3004721439-2026-00002
• Device Sequence Number: 5867026
• Product Code: JXG
• UDI-Device Identifier: 04041906131180
• UDI-Public: (01)04041906131180(11)250509(17)300410(10)20082590
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K011030
• 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): 02/27/2026

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: FV303T
• Device Catalogue Number: FV303T
• Device Lot Number: 20082590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2025
• 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