MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV427T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation results: visual inspection; scratches on the outer housing of the valves were observed through the visual inspection.No significant deformations or damage were detected.The measurement of the plane parallelism has shown that the valve was slightly outside the permissible tolerance, even though no apparent deformation was visible.Permeability test: a permeability test has shown that both valves are permeable with difficulty and bloody fluent leaked out.Computer controlled test to investigate over/under-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 progav® is operating within the accepted tolerance in the horizontal position.The shuntassistant® is not operating within the specified tolerances in the vertical position.Adjustment test: the progav® 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 operates as expected.However, the breaking force required was slightly outside the specified tolerances.Excessive force exerted on the surface of the housing, can impair the braking force.Results: it should be noted that the product was received dry (i.E.Not submersed in liquid as recommended).The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.First, we performed a visual inspection of the progav®.No significant deformations or damage, except scratches were detected during the visual inspection.The measurement of the plane parallelism, on the other hand, has shown that the valve is slightly outside the permissible tolerance with a value of -0.0310 mm.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.It was possible to adjust the progav® to all specified pressures.The braking function operates as required.Whereas the breaking force was slightly outside the permissible tolerances with a value of 710g.Both valves are permeable with difficulty and it could be observed that bloody fluent leaked out.The opening pressure of the progav® was within the required tolerance.The computer controlled test of the shunt assistant® could expose an underdrainage.Finally, we have dismantled the valves.Inside both valves we have found slight build-up of substances (likely protein).Based on our investigation, we confirm that the valve shows an slower flow of liquid 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 hg-therapy by shunt implants.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 (b)(4).No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that there was an issue with fv427t - progav system w/sa 20 a.Sprung reservoir.According to the complainant the valve dysfunction postoperatively.The valve was explanted and returned to the manufacturer for evaluation.Further details were not provided.

• Brand Name: PROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12579650
• Report Number: 3004721439-2021-00675
• Device Sequence Number: 3488322
• Product Code: JXG
• UDI-Device Identifier: 04041906132248
• UDI-Public: 4041906132248
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2021

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: 06/30/2020
• Device Model Number: FV427T
• Device Catalogue Number: FV427T
• Device Lot Number: 20028297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2016
• Initial Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention