MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SHUNTSYSTEM; HYDROCHEPHALUS MANAGEMENT

Model Number FX602T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

Height: 160 cm.Visual inspection: no significant deformations or damage of the valves were detected during the visual inspection.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.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 permeable and their opening pressures were operating within specifications.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 the progav 2.0 valve we have found slight build-up of substances (likely protein).There were no visible deposits observed inside the shuntassistant 2.0.Based on our investigation, we are unable to substantiate the claim of occlusion.At the time of our investigation, the valves were shown to be permeable.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 shunt system met all specifications of the final inspection when released from christoph miethke (b)(4).

Event Description

It was reported that the valve has a blockage.Due the malfunction, the valve was revised on (b)(6) 2020.Additional information was not provided.

• Brand Name: PROGAV 2.0 SHUNTSYSTEM
• Type of Device: HYDROCHEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; ulanenweg 2; potsdam 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO. KG; ulanenweg 2; potsdam 14469 ; GM 14469
• Manufacturer Contact: jörg knebel ; ulaneweg 2; potsdam 14469 ; GM 14469
• MDR Report Key: 10128856
• MDR Text Key: 194465019
• Report Number: 3004721439-2020-00100
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2024
• Device Model Number: FX602T
• Device Catalogue Number: FX602T
• Device Lot Number: 20043460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 60