MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS W/SA 25 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV435T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/24/2016
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 -0.0565 mm.Permeability test: a permeability test has shown that the valve is permeable.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 is fully operational and the braking force is within the given tolerances.Result: first, we performed a visual inspection of the progav¿.No deformations of the outer housing of the progav¿ valve were observed through the visual inspection.A slight deformation was observed through a measurement of the plan parallelity.Next, we tested the permeability, adjustability as well as the brake functionality and brake force.The valve operates as expected and met all specifications.Finally, we have dismantled the valve.Inside the valve we have found a small amount of build-up substances( like protein) past.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 fv435t - progav sys w/sa 25 a.Control reservoir.According to the complainant, the valve was believed to be blocked.The valve was explanted and returned to the manufacturer for evaluation.Further details were not provided.

• Brand Name: PROGAV SYS W/SA 25 A.CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12625120
• Report Number: 3004721439-2021-00681
• Device Sequence Number: 4290841
• Product Code: JXG
• UDI-Device Identifier: 04041906132477
• UDI-Public: 4041906132477
• 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: 09/29/2021
• Device Model Number: FV435T
• Device Catalogue Number: FV435T
• Device Lot Number: 20032039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2017
• 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