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

Model Number FV475T

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/20/2019

Event Type  Injury  

Manufacturer Narrative

Height: 170 cm.Investigation: visual inspection: except of slight scratches on the housing of the valve no significant deformations or damage of the valve were detected during the visual inspection.Permeability test: a permeability test has shown that the progav valve is only slightly permeable.Adjustment test: the progav valve was tested to adjust in all pressure levels up and down.The test has shown, that the valve is only adjustable within the pressure 0 - 11 cmh2o.In addition, an adjustment was not possible.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected.In addition, the braking force was within the expected tolerance, however only in the pressure range 0 - 11 cmh2o.In addition, it was not possible to measure the braking force because the valve was not adjustable.Computer controlled test: a computer controlled test was not performed.Results: first, we performed a visual inspection of the progav valve.Except of slight scratches on the housing of the valve no significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability.The test has shown that the valve is only slightly permeable.In the next step of investigation, it was only possible to adjust the valve within the opening pressure of 0 - 11 cmh2o.An adjustment beyond was not possible.The testing of the brake function was within the expected tolerance.However, it was not possible to test the braking force higher that a pressure rating of 11 cmh2o.Within the pressure levels 0 - 11 cmh2o the braking force is within the expected tolerance.Finally, we have dismantled the valve.Inside the valve, we have found slight build-up of substances (likely protein).Based on our investigation, we can confirm the presence of an occlusion.As described in scientific 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 (b)(4).

Event Description

It was reported the valve is blocked.The reporter indicated that a post operative valve is blocked.Additional event details have not been provided.

• Brand Name: PROGAV WITH SPRUNG RESERVOIR
• 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: 9384211
• MDR Text Key: 168249087
• Report Number: 3004721439-2019-00279
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141687
• 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: 11/27/2019

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 Model Number: FV475T
• Device Catalogue Number: FV475T
• Device Lot Number: 20012616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2010
• 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: 35 MO
• Patient Weight: 70