MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS W/SA 15 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV433T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: the valve was received submersed in an unidentified liquid in the provided returnkit.The valve was set to pressure range 0 cmh2o at the time of delivery.Visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.The examination of the parallelism, however, showed a slight deformation.Result: in the visual inspection of the valve, we could not detect any apparent damage.Nevertheless, the checking of the parallelism has shown a slight deformation.We suspect that the slight deformation was caused by a too powerful pressure on the valve.However, the further examination of the valve could exclude an impairment by the slight deformation.Further we carried out a permeability test.The investigation results that the valve was permeable.To proof if the brake function is full in place we carried out a brake function test.The investigation has shown that the brake function is present.Also the braking force is inside the accepted tolerance.Moreover, it was possible to adjust the valve in all pressure ranges up and down again in the same way.In order to make sure that the shunt assistant might have led to the suspected blockage, we also examined the shunt assistant.In the case of the shunt assistant, we have made a permeability test in the same way.The investigation has shown that the valve is permeable.Given the fact that during the treatment with shunts the following complications may arise (as described in the literature): infections, blockages caused by protein and/or blood in the cerebrospinal fluid, over/under drainage, we decided to dismantle the valves.Inside the valves we couldn't find deposits or substances of protein which might could have been the reason for the assumed difficulties with the occlusion in the past.Inside the shunt assistant we could as well do not find deposits or substances of protein.On the basis of our test results, we cannot confirm a blockage.There is no failure detectable with the valves at time of delivery.No further actions required.
Event or Problem Description
According to the complainant a progav was suspected of postoperative occlusion.The patient was originally implanted at an unspecified time.The event date was noted as (b)(6) 2016.The valve was explanted and returned to the manufacturer for evaluation.Further details were not provided.

• Brand Name: PROGAV SYS W/SA 15 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: 12480915
• Report Number: 3004721439-2021-00646
• Device Sequence Number: 3936419
• Product Code: JXG
• UDI-Device Identifier: 04041906132453
• UDI-Public: 4041906132453
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

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 Model Number: FV433T
• Device Catalogue Number: FV433T
• Device Lot Number: 20024432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2016
• Initial Report FDA Received Date: 09/16/2021
• 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
• Patient Age: 13 YR
• Patient Weight: 40