MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS PED.W/SA 20 A.BURRH.RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FV448T
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: visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.Even though no significant visual deformations were observed, the measurement of the plane parallelism has shown that the valve is slightly outside the permissible tolerance of 0 ± 0.02 mm with a value of -0.0665 mm.Permeability test: a permeability test has shown that the valve is permeable, albeit difficult.Deposits inside the valve may have impaired the permeability.Adjustment test: the progav® was tested and is not adjustable throughout the normal range.Braking force and brake function test: the brake functionality test has shown that the brake function is operational; however, the braking force cannot be measured due to the non-adjustability of the valve.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 results show that the valve operates within the accepted tolerance in the horizontal position.Result: it should be noted that the valve 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 of the valve were detected during the visual inspection.However, the measurement of the plane parallelism showed that the valve is outside the permissible tolerance at a value of -0.0665 mm.Excessive pressure on the valve can lead to a deformation of the housing.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The valve was permeable with difficulty and the opening pressure was within the accepted tolerance, but the valve could not be adjusted to all settings.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we confirm the non-adjustability at the time of our investigation but not the over- drainage.The deposits observed inside the valves could have caused the malfunction.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 valve 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 fv448t - progav sys ped.W/sa 20 a.Burrh.Res.According to the complainant, the valve was believed to be overdrainage.The valve was explanted and returned to the manufacturer for evaluation.Further details were not provided.

• Brand Name: PROGAV SYS PED.W/SA 20 A.BURRH.RES.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12627632
• Report Number: 3004721439-2021-00684
• Device Sequence Number: 4290843
• Product Code: JXG
• UDI-Device Identifier: 04041906132682
• UDI-Public: 4041906132682
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2021

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: 07/31/2017
• Device Model Number: FV448T
• Device Catalogue Number: FV448T
• Device Lot Number: 20017558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2017
• Initial Report FDA Received Date: 10/13/2021
• 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