MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS PED.W/SA25 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number FX442T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

When additional information becomes available a follow up report will be submitted.

Event Description

It was reported the valve was blocked.The reporter indicated that a one year post operative valve was blocked.Patient information was not provided.

Manufacturer Narrative

Investigation: visual inspection: no significant deformation:s or damage of the valves were detected during the visual inspection.Permeability test: a permeability test has indicated that both valves have blockages.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.Results: first, we performed a visual inspection of the progav 2.0 shunt system.No significant deformations or damage of the valves were detected during the visual inspection.Next, we tested the permeability and opening pressure of the valves.Both valves were shown to be non-permeable, indicating blockages.Additionally, we tested the adjustability as well as the brake functionality and brake force of the progav 2.0 valve.The valve operated as expected and met all specifications.Finally, we have dismantled the valves.Inside both valves, we have found slight build-up of substances (likely protein).Based on our investigation, we confirm the presence of occlusion in the system at the time of investigation.This is likely due to the deposits observed inside the valves.As described in our literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.The cause of the deformation of the progav 2.0 valve and the resultant defect of the rotor could not be determined through our investigation.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: PROGAV 2.0 SYS PED.W/SA25 A.PRECHAMBER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9588819
• MDR Text Key: 175093392
• Report Number: 3004721439-2020-00010
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K141687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: FX442T
• Device Catalogue Number: FX442T
• Device Lot Number: 20038775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 MO
• Patient Weight: 10