MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV SYSTEM W/PRECHAMB.ON VALVE 4/24; HYDROCEPHALUS MANAGEMENT

Model Number	FV304T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a paedigav (#fv304t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the valve caused an underdrainage.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 23 months.Height: 81.5 cm.Weight: 8.3 kg.Gender: female.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, visible deposits on the prechamber were determined.No significant deformation or other abnormalities could be determined.Permeability test: a permeability test has shown that the valve has a blockage.The prechamber is permeable.Computer controlled test: because the valve is not permeable, a computer-controlled test is not applicable.Internal inspection : after dismantling of the valve, deposits were found in paedigav.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 test results, we can detect a blockage in the valve.The visible deposits in the valve may have led to the occlusion.Deposits caused by natural substances in the body, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of proteins can impair the integrity of the valve.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: PAEDIGAV SYSTEM W/PRECHAMB.ON VALVE 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: 18771807
• Report Number: 3004721439-2024-00048
• Device Sequence Number: 4462754
• Product Code: JXG
• UDI-Device Identifier: 04041906131197
• UDI-Public: 4041906131197
• Combination Product (Y/N): N
• Initial Reporter Country: RW
• PMA/510(K) Number: K011030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/23/2024

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: FV304T
• Device Catalogue Number: FV304T
• Device Lot Number: 20056705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• 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: 23 MO
• Patient Sex: Female
• Patient Weight: 8 KG