MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA SET W/SPRUNG RESERVOIR MININAV 5; HYDROCEPHALUS MANAGEMENT

Model Number	FV713T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: during the visual inspection a damage of the outer housing of the prosa valve could be determined.The measurement of the plane parallelism could confirm that with a value of -0,141 mm - outside tolerance (0 ± 0.02 mm).Permeability test: a permeability test has shown that the prosa is permeable.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 valve is tested both the horizontal as well as the vertical position.Due to the brake function failure the computer- controlled test is not meaningful, as the valve cannot maintain the set opening pressure if the brake is defective.Adjustment test: the prosa valve was tested and is adjustable to all specified pressures.However, this was possible without any force being applied.The brake function is failed.Braking force and brake function test: the brake functionality test has shown that the brake function did not operate as expected.The results indicate that the rotor no longer performs as required.Internal inspection: after dismantling of the valve, deposits were found in prosa.Results: based on our investigation results, we can determine a damage of the outer housing of the valve as well a brake function failure.The determined damage of the outer housing can be named as the cause for the brake function failure.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.
Event or Problem Description
It was reported that a prosa (part # fv713t) was implanted during a procedure performed on (b)(6) 2019.According to the complainant, the shunt system was believed to be operated in underdrainage and had adjustment difficulties.The patient underwent a revision procedure performed on (b)(6) 2023.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 10.6 years.Height: 147 centimeters (cm).Weight: 38 kilograms (kg).Gender: female.Same event as medwatch# 3004721439-2023-00019.

• Brand Name: PROSA SET W/SPRUNG RESERVOIR MININAV 5
• 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: 16329585
• Report Number: 3004721439-2023-00018
• Device Sequence Number: 15617683
• Product Code: JXG
• UDI-Device Identifier: 04041906133955
• UDI-Public: 4041906133955
• 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: 2023
• 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): 02/08/2023

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: 02/14/2023
• Device Model Number: FV713T
• Device Catalogue Number: FV713T
• Device Lot Number: 20036751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2018
• 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: 10 YR
• Patient Sex: Female
• Patient Weight: 38 KG