MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA20 AND DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX420T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: ( description incoming product condition) the valve was received inserted in an unknown liquid.The device was noted to have been manufactured in april 2016.At the time of submission the valve was set to pressure range 3 cmh2o.Summary: first we performed a visual inspection with the valve.Apart from slight scratches on the housing, we could not detect any deformations or other abnormalities.To investigate if maybe a blockage have caused the assumed problems with re-programming the valve, we performed a permeability test.The test results that the valve was penetrable.For further information we tried to adjust the valve from 0 cmh2o up to 20 cmh2o and down again in the same way in steps of 2 cmh2o.Based on our investigation results we cannot confirm any difficulties in adjusting the valve.It was possible to adjust the valve in all pressure ranges.The measurement of the braking force could additionally confirm that the measured value was within the accepted tolerance.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.The opening pressure at the reference flow level of 5 ml/h is measured 4,08 cmh2o.The progav 2.0 operates reliably within the accepted tolerance (acc.Tolerance 5 +/- 2 cmh2o).In order to verify whether the valve examined here has been influenced by the known risks of hydrocephalus therapy, as for example by natural substances (protein, blood or tissue particles) in the cerebrospinal fluid, we have finally opened the valve.After the valve has been opened we have found obvious deposits inside the valve, which could have impaired the product performance in the past.Based on our investigation results we cannot confirm that it was not possible to adjust the valve in lower values.The valve could easily be adjusted in all pressure ranges.However, we are able to detect deposits inside the valve that might have been a cause in the past.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 had a malfunction postoperatively.The patient was originally implanted on an unspecified date.The product was explanted since attempts to re-adjust the valve were unsuccessful (unable to set the opening pressure to a lower value), and returned to the manufacturer for evaluation.The event date was noted as (b)(6) 2016.Further details were not provided.

• Brand Name: PROGAV 2.0 WITH SA20 AND DISTAL CATHETER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12577914
• Report Number: 3004721439-2021-00683
• Device Sequence Number: 13728432
• Product Code: JXG
• UDI-Device Identifier: 04041906136628
• UDI-Public: 4041906136628
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141687
• 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): 10/05/2021

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: FX420T
• Device Catalogue Number: FX420T
• Device Lot Number: 20029912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2016
• Initial Report FDA Received Date: 10/05/2021
• 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