MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV VENTIL 9/29; HYDROCEPHALUS MANAGEMENT

Model Number	FV295T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing and quality control data the paedigav was manufactured by a qualified employee in (b)(6)2015.Deviations during assembly did not occur.The valve was inspected as article fv295t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Visual inspection: no significant deformations or other abnormalities of the valve were detected during the visual inspection.Permeability test: a permeability test has shown that the valve is permeable.Computer controlled test: to investigate the claim of over/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 is operating within the accepted tolerance in the horizontal but not in the vertical position.Internal inspection : after dismantling of the valve, some deposits were found in paedigav.Results: based on our investigation, we confirm that the valve shows an increased flow of liquid, likely due to the deposits observed inside the valve.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from (b)(4) kg.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a paedigav was implanted during a procedure performed in 2013.According to the complainant, the shunt system was believed to be operated in 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: (b)(6).Height: 120 cm.Weight: unknown.Gender: male.

• Brand Name: PAEDIGAV VENTIL 9/29
• 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: 13077884
• Report Number: 3004721439-2021-00335
• Device Sequence Number: 4278915
• Product Code: JXG
• UDI-Device Identifier: 04041906114565
• UDI-Public: 4041906114565
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K011030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2021

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: 12/31/2019
• Device Model Number: FV295T
• Device Catalogue Number: FV295T
• Device Lot Number: 20026988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2015
• 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: 8 YR
• Patient Sex: Male