MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number	FX434T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/31/2016
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.The valve was set to pressure range 8 cmh2o at time of receipt.Visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.Result: in the visual inspection of the valve, we could not detect any apparent damage.It was possible to adjust the valves up and down again in steps of 5 cmh2o and in steps of 2 cmh2o in the same way.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 within the accepted tolerance.Further we carried out a permeability test.The investigation has resulted that the valve is permeable.As a final examination we carried out a computer controlled test.Here the progav 2.0 was tested in the lying position with a pressure range of 5 cmh2o.Normally we expected a pressure of 5 cmh2o having an opening pressure of 5 cmh2o.At the first test the opening pressure at the reference flow level of 5 ml/h is measured 1,12 cmh2o.The progav 2.0 valve tends to an over-drainage.We execute a second test.At the second test the opening pressure at the reference flow level of 5 ml/h is measured 0,44 cmh2o.The second test showed no improvement.The valve is not working inside the accepted tolerance (accepted tolerance of 5 ± 2 cmh2o).We suspect that deposits inside the valve may have affected the product performance.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 or in very rare cases, noise development, we decided to dismantle the valve.Inside the valve we have found deposits or substances of protein, which probably could have caused the observed over-drainage.There was no failure detectable at the time of delivery.No further actions required.
Event or Problem Description
According to the complainant a progav was suspected of postoperative blockage.The patient was originally implanted on (b)(6) 2016.The explant date was (b)(6) 2016.The valve was returned to the manufacturer for evaluation.Further details were not provided.

• Brand Name: PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12480873
• Report Number: 3004721439-2021-00635
• Device Sequence Number: 17127666
• Product Code: JXG
• UDI-Device Identifier: 04041906137328
• UDI-Public: 4041906137328
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• 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: FX434T
• Device Catalogue Number: FX434T
• Device Lot Number: 20028896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2016
• 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