MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV SYSTEM 4/24; HYDROCEPHALUS MANAGEMENT

Model Number	FV278T
Medical Device Problem Codes	Obstruction of Flow (2423); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: no product received to date.Should relevant additional information/investigation results become available, an additional medwatch report will be submitted.
Event or Problem Description
It was reported that a paedigav valve (#fv278t) was implanted and explanted.So far, we have no information about the reason for the explant.The complained product was not yet sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.
Event or Problem Description
It was reported that a ventricular cathetre from a paedigav shunt system (#f v278t) was implanted on (b)(6) 2019 and explanted on (b)(6) 2024.The ventricular catheter was explanted due to a blockage.The complained product was sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Manufacturing site evaluation: visual inspection: during the investigation, visible depositis on the perforation and calcification on the catheter were determinde permeability test: a permeability test has shown that the cathter is permeable.Results: based on our investigation results, we can determine visible deposits on the perforation of the ventricular catheter.The deposits had no effect upon the specifications at the time of the examination.The catheter is permeable.Organic material in the csf can temporarily influence the function and are known side effects in hydrocephalus therapy.We can exclude a defect at the time of release.The product met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.The examination of the return has been completed with the drafting of this report.

• Brand Name: PAEDIGAV SYSTEM 4/24
• 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: 21348363
• Report Number: 3004721439-2025-00022
• Device Sequence Number: 7853856
• Product Code: JXG
• UDI-Device Identifier: 04041906115401
• UDI-Public: 4041906115401
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K011030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• 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): 03/10/2025

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 Expiration Date: 11/30/2022
• Device Model Number: FV278T
• Device Catalogue Number: FV278T
• Device Lot Number: 20036208
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2018
• 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