MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG GAV VALVE 10/40; HYDROCEPHALUS MANAGEMENT

Model Number FV314T

Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.Permeability test: a permeability test has shown that the valve is only slightly permeable.Adjustment test: the adjustment test is not applicable, because the gav is a valve with a fixed pressure.Braking force and brake function test: the braking force and brake function test is not applicable, because the gav is a valve with a fixed pressure.Computer controlled test: to verify the suspicion of an over-drainage and blockage, the valve was tested on our miethke computer controlled testing apparatus, which simulates a cerebrospinal fluid flow.The valve was tested in the horizontal position with an opening pressure of 10cmh2o and in the vertical position as well with an opening pressure of 40 cmh2o.In the horizontal position, the valve operates within the acceptable tolerance.In the vertical position, the valve operates slightly outside the acceptable tolerance, with a tendency to an over-drainage.Results: first, we performed a visual inspection of the gav valve.No significant deformations or damage of the valve were detected during the visual inspection.Further, we tested the permeability of the valve.The test has shown that the valve is only slightly permeable.The testing of the adjustability, the brake functionality and as well the brake force are not applicable, because the valve has a fixed pressure to verify the suspicion of an over-drainage or blockage, we carried out a computer controlled test.The measured opening pressure in the horizontal position was within the accepted tolerance.The measured opening pressure on the vertical position was slightly lower than accepted.The valve tends to an over-drainage in the vertical position.Finally, we have dismantled the valve.Inside the valve, we have found slightly but visible substances (likely protein).Based on our investigation, we can confirm that the gav valve operates with a tendency to an over-drainage.Presumably caused by deposits inside the valve.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.

Event Description

It was reported over drain of the valve.The reporter indicated that a post operative valve is over draining.Additional details have not been provided.

• Brand Name: GAV VALVE 10/40
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9366820
• MDR Text Key: 167952635
• Report Number: 3004721439-2019-00278
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2019

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: 01/14/2023
• Device Model Number: FV314T
• Device Catalogue Number: FV314T
• Device Lot Number: 20036282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 MO
• Patient Weight: 8