MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV 2.0 SYS W/PED.CONTROL RESERV.5/25; HYDROCEPHALUS MANAGEMENT

Model Number	FX153T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: no significant damages of the ped.Control reservoirs were determined during the visual inspection.Permeability test: a permeability test has shown that the ped.Control reservoir is permeable.Results: based on our investigation results, we cannot determine any functional deviations or other abnormalities at the ped.Control reservoir.The product operated within its specification.The examination of the return has been completed with the drafting of this report.We can exclude a defect at the time of release.The reservoir met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point view.
Event or Problem Description
It was reported that a ped.Control reservoir (part of fx153t) was implanted during a procedure on (b)(6) 2024.According to the complainant, the reservoir caused underdrainage.The reservoir was revised on (b)(6) 2024.No complications were reported in the patient as a result of the revision procedure.The product in question was sent to the manufacturer for investigation.

• Brand Name: GAV 2.0 SYS W/PED.CONTROL RESERV.5/25
• 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: 21949354
• Report Number: 3004721439-2025-00141
• Device Sequence Number: 18281235
• Product Code: JXG
• UDI-Device Identifier: 04041906142926
• UDI-Public: 4041906142926
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 05/02/2025

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: FX153T
• Device Catalogue Number: FX153T
• Device Lot Number: 20075759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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: 6 MO
• Patient Sex: Male