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	02/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a prosa (part # fv713t) was implanted during a procedure performed in (b)(6) 2022.According to the complainant, the shunt system was believed to be operated in overdrainage and difficult to adjust.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: (b)(6).Height: 178 centimeters (cm).Weight: (b)(6).Gender: female.
Additional Manufacturer Narrative
Investigation: visual inspection: a deformation of the outer housing of the prosa valve was observed through the visual inspection.A measurement of the plane parallelism could confirm this.The prosa valve housing was subsequently measured and confirmed/indicated the presence of a deformation.The housing deformation measured at -0.072 mm, outside the tolerance of 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 adjustable to all specified pressures.The brake function was not given.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.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.The brake function was not given and so the opening pressure could not be hold.A computer controlled test is not applicable.Internal inspection: after dismantling of the valve, no deposits were found in the valve.Results: we would like to note in advance that the returned product was not submerged in liquid at the time of receipt.The testing of valves sent in a dry condition is only of a limited value.The product performance can be affected by dry residues of cerebrospinal fluid or blood.Despite this we have tested the device to the best of our abilities.For the sake of thoroughness and transparency, we would like to point out that an adjustment test was already carried out after the revision at the hospital.Based on our investigation results, we have determined that there was a malfunction of the brake and a deformation of the valve housing e at the time of our investigation.The cause of the brake malfunction is the deformation of the housing surface.Excessive pressure with the adjusting instrument may damage the housing of the valve and impair its function.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke (b)(4) & co.(b)(4).No further regulatory actions are required from our point of view.

• 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: 13943976
• Report Number: 3004721439-2022-00069
• Device Sequence Number: 6505890
• 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 Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2022

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 Model Number: FV713T
• Device Catalogue Number: FV713T
• Device Lot Number: 20056149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 78 KG