MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA15 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX351T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: ( description incoming product condition) we received the valve in the return kit.The valve was inserted in an unknown liquid.The progav 2.0 was set to pressure range 20 cmh2o at the time of submission for investigation.In the visual inspection of the valve, we could not detect any apparent damage.It was possible to adjust the valve up and down again in steps of 5 cmh2o.To prove 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.Further we carried out a permeability test.The investigation has resulted that the valve is difficult permeable.We assume that protein deposits or blood may have caused the impermeability.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 test the opening pressure at the reference flow level of 5 ml/h is measured 3,93cmh2o.The valve is working inside the tolerance (accepted tolerance of 5 ± 2 cmh2o).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 could find apparent deposits or substances of protein which might could be the reason for the assumed difficulties.Based on our investigation results we could not detect any failure with the valve at the time of delivery.No further actions required.
Event or Problem Description
According to the complainant a progav was very difficult to reprogram postoperatively.The patient was originally implanted on an unknown date.The event date was noted as (b)(6) 2016.The valve was explanted and returned to the manufacturer for evaluation.The patient was a "complex hydrocephalus child".Further details were not provided.

• Brand Name: PROGAV 2.0 WITH SA15 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: 12377968
• Report Number: 3004721439-2021-00600
• Device Sequence Number: 3924940
• Product Code: JXG
• UDI-Device Identifier: 04041906140007
• UDI-Public: 4041906140007
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

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: FX351T
• Device Catalogue Number: FX351T
• Device Lot Number: 20027675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2016
• Initial Report FDA Received Date: 08/27/2021
• 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: 2 YR