MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV VALVE; HYDROCEPHALUS MANAGEMENT

Model Number FV410T

Device Problem Infusion or Flow Problem (2964)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

Height: 156 cm.When additional information becomes available a follow up report will be submitted.

Event Description

It was reported that the valve was under draining.The reporter indicated that a 8 year 7 month post operative valve is under draining.Additional details of the event have not been provided.

Manufacturer Narrative

Investigation visual inspection scratches on the outer housing of the valve were observed through the visual inspection.No significant deformations or damage was detected.Permeability test a permeability test has shown that the progav valve is permeable.Adjustment test the progav 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 investigate the claim of over/under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The progav valve is operating within acceptable tolerances.Results first, we performed a visual inspection of the progav 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 valve operates as expected and met all specifications.Finally, we have dismantled the valve.Inside the valve we have found slight build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of under-drainage.At the time of our investigation, the opening pressure of the progav valve was within the specified tolerances.However, it is possible that the deposits observed inside the valve could have caused the malfunction in the past.As described in our literature.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 VALVE
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8962881
• MDR Text Key: 160747114
• Report Number: 3004721439-2019-00220
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K110206
• 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: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: FV410T
• Device Catalogue Number: FV410T
• Device Lot Number: 450309444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 MO
• Patient Weight: 61