MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0; PRO GAV

Model Number FX410T

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that the vale is not adjustable.

Manufacturer Narrative

Investigation: visual inspection scratches on the outer housing of the valve were observed through the visual inspection.No significant deformations or damage were detected.Permeability test a permeability test has shown that the progav 2.0 valve is 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.Result first, we performed a visual inspection of the progav 2.0 valve.No significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The progav 2.0 valve operates as expected and met all specifications.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of automatic adjustment.At the time of our investigation, the progav 2.0 was able to be adjusted to all specified settings and the adjusted pressure stage was maintained.However, it is possible that the deposits observed inside the valve could have caused the malfunction in the past.As described in our literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: PROGAV 2.0
• Type of Device: PRO GAV
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam, D-144 69; GM D-14469
• MDR Report Key: 7659511
• MDR Text Key: 113271514
• Report Number: 3004721439-2018-00121
• 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: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX410T
• Device Catalogue Number: FX410T
• Device Lot Number: 20025388
• Distributor Facility Aware Date: 06/05/2018
• Date Manufacturer Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 5 YR
• Patient Weight: 24