MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA SYS W/ADJ.DP.UNIT A.CONTROL RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FV770T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an implanted prosa shunt system (# fv770t), accordingly to the complainant, showed an over-drainage.The patient underwent a revision procedure performed on (b)(6) 2024.The complainant device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 21 years.Gender: female.
Additional Manufacturer Narrative
Visual inspection: during the investigation, some residue tissues on the valves were determined.During the visual inspection a deformation of the outer housing of the prosa valve could be determined.The measurement of the plane parallelism confirmed that the value was not in the given tolerances.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to investigate the claim of over- drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.All measurements show that both valves operate within the accepted tolerance.Adjustment test: the prosa and the progav valves were tested and are adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function of the prosa operates as expected.However, the breaking force required was not within the given specifications.The brake function of the progav is fully operational and the braking force is within the given tolerances.Internal inspection: after dismantling of the valves, deposits were found in both valves.Results: based on our investigation results, we can determine deposits and a deformation of the prosa housing.The deposits, as well as the deformation, had no affect 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 matter 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.No further regulatory actions are required from our point of view.

• Brand Name: PROSA SYS W/ADJ.DP.UNIT A.CONTROL RES.
• 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: 19335157
• Report Number: 3004721469-2024-00118
• Device Sequence Number: 2972218
• Product Code: JXG
• UDI-Device Identifier: 04041906135553
• UDI-Public: 4041906135553
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/16/2024

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: 05/09/2022
• Device Model Number: FV770T
• Device Catalogue Number: FV770T
• Device Lot Number: 2003384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2017
• 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: 21 YR
• Patient Sex: Unknown