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	08/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: during the visual inspection a deformation of the outer housing of the prosa valve could be determined.The measurement of the plane parallelism could confirm that with a value of -0,068 mm - outside tolerance (0 ± 0.02 mm).Permeability test: a permeability test has indicated that the progav valve has a blockage and that the prosa is permeable.During the permeability test bloody liquid were flushed out.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 valves are tested in both the horizontal as well as the vertical positions.The results show that the prosa operates within the accepted tolerance in the vertical positions.Because the progav valve is not permeable, a computer controlled test is not possible.Adjustment test: the progav and the prosa were tested and are adjustable to all specified pressures.Braking force and brake function test: the brake functionality test on both valves has shown that the brake function is fully operational and the braking force is within the given tolerances.Internal inspection: after dismantling of the valves, deposits were found in progav but not in prosa.To make the proteins / deposits in the shunt system more visible, they were colored using a staining solution.Results: based on our examination results, we can determine, at the time of our examination, a blockage at the progav.The cause of this could be the deposits detected.Deposits caused by substances naturally present in the body, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of protein can compromise the integrity of the valve.Furthermore, we have observed deformation of the housing membrane at the prosa.Excessive pressure, e.G.From the adjustment instrument, could be responsible for this.We can exclude a defect at the time of release.The shunt system 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 shuntsystem mit progav (#fv770t) was implanted during a procedure performed on unknown.According to the complainant, the shunt showed an over-drainage.The patient underwent a revision procedure performed on (b)(6) 2023.The complainant device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 58 years.Weight: 80 kilograms.Height: 178 centimeters.Gender: female.

• 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: 17691819
• Report Number: 3004721439-2023-00260
• Device Sequence Number: 6032613
• 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: 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): 09/06/2023

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: 01/24/2023
• Device Model Number: FV770T
• Device Catalogue Number: FV770T
• Device Lot Number: 20036479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2018
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 80 KG