MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS PED.W/SA 10 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FV439T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/09/2023
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 progav shuntsystem (#fv439t) was implanted during a procedure performed on (b)(6) 2021 according to the complainant, the shunt showed an over-drainage.The patient underwent a revision procedure performed on (b)(6) 2023.The complainant device has not yet returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 66 y weight: 78 kgs height: 170 cm gender: female.
Additional Manufacturer Narrative
Investigation: visual inspection: no significant deformations or damage of the valve were detected during the visual inspection, but the measurement of the plane parallelism has revealed with a value of - 0.032 mm [outside the tolerance of 0 ± 0.02 mm] a deformation.Permeability test: a permeability test has shown that the valve is permeable.Computer controlled test: to investigate the claim of over- drainage, the opening pressure is measured using a miethke computer controlled test bench which simulates a cerebrospinal fluid flow.The valve is tested in the horizontal position.The results show that the valve operates within the accepted tolerances in the horizontal position.Adjustment test: the progav was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Internal inspection : after dismantling of the valve, deposits were found.Result : based on our investigation results, we can determine a deformation and deposits.Both had no effect to the technical properties at the time of the investigation.The cause of the aforementioned functional impairment is not known to us at the time of the examination.Organic material in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.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.
Event or Problem Description
The sample was returned for investigation to the manufacturer on 01/25/2024.The release was submitted on 02/15/2024.

• Brand Name: PROGAV SYS PED.W/SA 10 A.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: 18344874
• Report Number: 3004721439-2023-00376
• Device Sequence Number: 5531820
• Product Code: JXG
• UDI-Device Identifier: 04041906132521
• UDI-Public: 4041906132521
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 02/22/2024

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 Expiration Date: 10/08/2024
• Device Model Number: FV439T
• Device Catalogue Number: FV439T
• Device Lot Number: 20044286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2019
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 78 KG