MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROSA WITH PROGAV 2.0; HYDROCEPHALUS MANAGEMENT

Model Number FX992T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

Height: 165cm.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 one year ten month post-operative valve is over draining.The device was explanted.Additional event details is not available.

Manufacturer Narrative

Investigation.Visual inspection: in the first step of our investigations a visual check is performed.It is verified if defects, deformations or other abnormalities could be detected.Permeability test: to check if the valve is blocked, a test of permeability is performed.This test is performed at the calculated hydrostatic height (opening pressure of the valve plus 30cmh2o) in horizontal flow direction.Measurement of plane-parallelism: a measuring device is used to measure the plane-parallelism of the valve housing.Adjustment test: the adjustment test is performed to check if the prosa could be adjusted to all pressure settings.An adjustment test is performed in steps of 4 to adjust the valve up and down in the pressure settings in question.Braking force and brake function test: to measure the braking force, the prosa valve is checked with a braking force measurement device.This device measures the force, which needs to be exerted on the housing to release the rotor in order to adjust the valve by the magnet integrated in the device.Computer controlled test: to investigate the claim of over-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus, which simulates a cerebrospinal fluid flow.Results: first we performed a visual inspection of the prosa valve.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 valve operated as expected, however the brake force was outside of tolerance.All other specifications were met.This deviation could have been caused by the deformation of the outer housing.Finally, we have dismantled the valve.Inside the valve, we have found a minimal build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of over-drainage.At the time of our investigation, the opening pressure of the prosa valve was within the specified tolerances.Despite the lack of significant deposits, it is possible that even non-visible or small amounts of build-up could have led to a temporary compromise of the valve and to the observed malfunction in the past.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 WITH PROGAV 2.0
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9868409
• MDR Text Key: 188550769
• Report Number: 3004721439-2020-00070
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K141687
• 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: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2023
• Device Model Number: FX992T
• Device Catalogue Number: FX992T
• Device Lot Number: 20036592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Weight: 70