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

Model Number	FV701T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a prosa (#fv701t) was implanted combined with a progav 2.0 (#fx410t) and a shuntassistant (fv252t) during a procedure performed on (b)(6) 2020.According to the complainant, the valve caused an 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: 34 years; height: 160 cm; weight: 65 kg; gender: female.Same event as medwatch#3004721439-2023-00355 and #3004721439-2023-00357.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, a deformation of the outer housing could be determined during the visual inspection.The measurement of the plane parallelism has confirmed this with a value of -0.054 mm - outside the tolerance of 0 ± 0.02 mm.Permeability test: a permeability test has shown that all components are permeable.Computer control test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer control testing bench which simulates a cerebrospinal fluid flow.The valve is tested in both the horizontal as well as the vertical position.Adjustment test: the prosa valve 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, no deposits were found in the prosa.Results: based on our investigation results, we cannot determine a functional deviation or other abnormalities.The cause of the aforementioned functional impairment is not known to us at the time of the examination.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
• 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: 18247000
• Report Number: 3004721439-2023-00356
• Device Sequence Number: 7191320
• Product Code: JXG
• UDI-Device Identifier: 04041906133023
• UDI-Public: 4041906133023
• 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: 2020
• Device Explanted Year: 2023
• 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): 12/01/2023

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: 05/13/2025
• Device Model Number: FV701T
• Device Catalogue Number: FV701T
• Device Lot Number: 20047837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2020
• 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: 34 YR
• Patient Sex: Female
• Patient Weight: 65 KG