MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA VALVE WITH DIST.KATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FV709T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a prosa valve (part # fv709t) was implanted during a procedure performed on (b)(6) 2019.According to the complainant, the shunt system was believed to be operated in underdrainage.The patient underwent a revision procedure on (b)(6) 2022.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 20 years, height: 155 centimeters (cm), weight: 70 kilograms (kg), gender: male.
Additional Manufacturer Narrative
Manufacturing and quality control data.The prosa® was manufactured by a qualified employee in (b)(6) 2017.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The prosa® has a normal pressure range of 0 to 40 cmh2o.The valve was inspected as article fv709t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Visual inspection: a deformation of the outer housing of the /prosa valve was observed through the visual inspection.The measurement of the plane parallelism could confirm that with a value of -0,101 mm the housing membrane is clearly outside tolerance (0 ± 0.02 mm).Permeability test: a permeability test has shown that the valve is permeable.Adjustment test: the prosa® valve was tested and is not adjustable throughout the normal range.Braking force and brake function test: the brake functionality test has shown that the brake function is operational, however the braking force cannot be measured due to the non-adjustability of the valve.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The results show that the valve operates within the accepted tolerance in vertical position.Internal inspection: after dismantling of the valve, deposits were found in prosa®.Results: based on our investigation, we confirm that the was non-adjustable at the time of our investigation.This is likely due to the deposits observed inside the valves.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 christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.

• Brand Name: PROSA VALVE WITH DIST.KATHETER
• 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: 15524692
• Report Number: 3004721439-2022-00300
• Device Sequence Number: 14977467
• Product Code: JXG
• UDI-Device Identifier: 04041906133580
• UDI-Public: 4041906133580
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2022

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: 09/05/2022
• Device Model Number: FV709T
• Device Catalogue Number: FV709T
• Device Lot Number: 20035031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2017
• 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: 20 YR
• Patient Sex: Male
• Patient Weight: 70 KG