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

Model Number FV701T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

Height: 130cm.Visual inspection no significant deformations or damage of the valves were detected during the visual inspection.Permeability test: a permeability test has shown that the valve is permeable.Adjustment test: the adjustment test has shown that the prosa is adjustable to all settings, even if high pressure was necessary.Braking force and brake function test: the investigation of the braking force of the prosa valve showed that the brake function is fully operational.However, the braking force was out of tolerance.Computer controlled test: the test is performed with a miethke computer controlled testing apparatus.The valve was tested by simulating a cerebrospinal fluid flow at rates between 60 ml/h down to 5 ml/h and up again to 60 ml/h in the vertical and horizontal position (in acc.To iso 7197).Distilled water is used as test-liquid.The opening pressure is expected to measure at the reference flow rate 0 ± 4 cmh2o in the vertical position.Results first, we performed a visual inspection of the valves.No significant deformations or damages of the valve was detected during the visual inspection.Further, we tested the permeability of the valve.The test has shown that the valve was permeable.The testing of the adjustability, the brake functionality and as well the brake force of the prosa valve was possible.Except of the braking force, the test values were within the expected tolerances.To investigate the suspicion of an over-drainage, the opening pressure is measured by using a miethke computer controlled testing apparatus, which simulates a cerebrospinal fluid flow.The prosa is tested in the vertical position.The opening pressure in the vertical position at a reference flow level of 5 ml/h was measured at -7,68 cmh2o.The valve is not operating within the acceptable tolerance [tolerance 0 ± 4 cmh2o].A second test was done.The opening pressure in the second test was measured at -7, 16 cmh2o.There was no significant improvement in the values.Finally, we have dismantled the valve.Inside the valve, we have found a build-up of substances (likely protein.Based on our investigation, we can confirm that the prosa valve is over-draining, likely due to build-up of protein deposits.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.Nevertheless, 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.

Event Description

It was reported that a valve is over draining.The reporter indicated that a post-operative valve is operating in over drainage and required explantation.Additional event details were not provided.

• Brand Name: PROSA VALVE
• 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: 9681656
• MDR Text Key: 178262741
• Report Number: 3004721439-2020-00036
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K120559
• 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: 02/07/2020

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: 10/26/2021
• Device Model Number: FV701T
• Device Catalogue Number: FV701T
• Device Lot Number: 20032101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 02/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2016
• 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: 10 YR
• Patient Weight: 50