MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROSA SYS W/PROGAV 2.0 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number FX991T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

When additional information becomes available a follow up report will be submitted.

Event Description

It was reported that there is an issue with valve.The reporter indicated that a 2 month 4 day post-operative valve has a dysfunction.The device was explanted.Additional event details and patient information have not provided, however, have been requested.

Manufacturer Narrative

Investigation.Visual inspection: a deformation of the outer housing of the prosa valve was observed through the visual inspection.The prosa valve housing was subsequently measured and confirmed the presence of a deformation.The housing deformation measured at -0.052mm, outside the tolerance of 0 =/- 0.02mm.Permeability test a permeability test has shown that the prosa valve is permeable.Computer controlled test to investigate the claim of underdrainage, the opening pressure is measured using a miethke computer controlled testing apparatus, which simulates a cerebrospinal fluid flow.The prosa valve is operating within acceptable tolerances, but the measured values of the posa valve were outside the acceptable tolerance.Therefore we can confirm an under drainage.Adjustment test the posa 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 operates as expected.However, the braking force of both valves required was not within the given specifications.Results first, we performed a visual inspection of the system.A deformation of the outer housing of the prosa valve was observed through the visual inspection.This deformation was confirmed through a measurement of the plan parallelity.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The opening pressure and the brake force of the prosa valve were out of tolerance, but all other specifications were met.The opening pressure of the prosa was significantly higher than expected, indicating a tendency towards under drainage.Except the brake force, all specification of the progav 2.0 valve were within the required tolerances.Finally, we have dismantled the valve.Inside the valves, we have found a significant build-up of substances (likely protein).Based on our investigation, we can confirm that the prosa valve was operating in an under-drainage state at the time of our investigation.In addition, the brake force of both valves was outside the tolerance.This is likely due to the significant deposits observed inside the valves.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.The cause of the deformation of the prosa valve could not be determined through our investigation.Significant outside pressure, for example by too much force from the prosa adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve.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.

• Brand Name: PROSA SYS W/PROGAV 2.0 A.CONTROL RESERV.
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9787084
• MDR Text Key: 182009282
• Report Number: 3004721439-2020-00057
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX991T
• Device Catalogue Number: FX991T
• Device Lot Number: 20044426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 65