MAUDE Adverse Event Report: CHRISTOPHER METHKE GMBH & CO. KG PROGAV 2.0 SYS W/SA25 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number FX428T

Device Problem Restricted Flow rate (1248)

Patient Problem Failure of Implant (1924)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "4m 18d po underdrain of valve." additional information has been requested however, not yet received.If additional information is received a follow up report will be submitted.

Manufacturer Narrative

Investigation: visual inspection: scratches on the outer housing of the valves were observed through the visual inspection.No significant deformations or damage were detected.Permeability test: a permeability test has shown that both valves are permeable.Adjustment test: the progav 2.0 valve 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.Computer controlled test: to test the opening pressure, we use a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.Both valves are operating within acceptable tolerances.Results: finally, we have dismantled the valves.There were no visible deposits inside the valves.Based on our investigation, we are unable to substantiate the claim of underdrainage.The valves operate within the specified tolerances.Despite no visible deposits being observed, it is possible that even a small amount of non-visible blood or protein can lead to a temporary blockage and could be responsible for the suspected malfunction in the past.As described in our literature, the problem described is one of the known, inevitable risks of hc-therapy by shunt implants.

• Brand Name: PROGAV 2.0 SYS W/SA25 A.SPRUNG RESERVOIR
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPHER METHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8310174
• MDR Text Key: 135158393
• Report Number: 3004721439-2019-00024
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2023
• Device Model Number: FX428T
• Device Catalogue Number: FX428T
• Device Lot Number: 20038541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Distributor Facility Aware Date: 02/01/2019
• Device Age: 6 MO
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention