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

Model Number FV701T

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hydrocephalus (3272)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an unspecified issue with the shunt system.A prosa valve was being returned to the manufacturer and the surgeon requested that it be "checked for protein".Additional information is expected upon receipt of the return kit.

Manufacturer Narrative

Reason for complaint: suspician of occlusion.Date of removal: (b)(6) 2019.Manufacturing evaluation: the valve was received submersed in an unidentified liquid.Visual inspection - a deformation of the outer casing was detected.The valve housing was subsequently measured and confirmed the presence of a deformation, outside the tolerance.Permeability test - results have shown that the valve was permeable.Adjustment test - the valve was not fully adjustable to specifications.Braking force and function test - the brake function was operational, but the braking force could not be measured due to the non-adjustability.Results - after the tests, we have dismantled the valve.Inside the valve we found a significant build-up of substances (likely protein).Based on our investigation, we are unable to confirm that the valve was blocked.However, it is possible that the deposits observed inside the valves could have caused the observed malfunction in the past and led to a temporary blockage.As described in our literature, the problem encountered is one of the known, inevitable risks of hydrocephalus (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.

• Brand Name: PROSA VALVE
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9105468
• MDR Text Key: 160051829
• Report Number: 3004721439-2019-00242
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K161853
• 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: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FV701T
• Device Catalogue Number: FV701T
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention