MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROSA SYS W/ADJ.DP.UNIT A.CONTROL RES.; HYDROCEPHALUS MANAGEMENT

Model Number FV770T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/17/2020

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 3 year 4 day post-operative valve has a blockage and a dysfunction.The device was explanted.Additional event details and has not provided, however, have been requested.

Manufacturer Narrative

Investigation: visual inspection: in the first step of our investigations a visual inspection is performed.It is tested whether any defects, deformations or other abnormalities are to be detected.Permeability test: to proof the penetrability of the valve we have carried out a penetrability test.This test is carried out at a hydrostatic pressure of approximately 30 cmh2o + 11 cmh2o in the horizontal flow direction.Computer controlled test: the test is performed with a miethke computer controlled testing apparatus.The progav was tested by simulating a cerebrospinal fluid flow at rates between 60 ml/h down to 5 ml/h in the horizontal and vertical position (in acc.To iso 7197).Distilled water is used as test-liquid.Adjustment test: the adjustment test is used to examine whether progav valve can be adjusted in all pressure levels.The attempt is made to move the valve up and down in steps of 5cmh2o in the corresponding pressure range.Braking force and brake function test: to measure the braking force, we tested the progav valve with a braking force apparatus.Here it is measured how much force must be exerted on the housing to release the rotor to adjust the valve by the integrated magnet of the braking force apparatus.Results: first, we performed a visual inspection of the progav.No significant deformations or damage of the valve were detected during the visual inspection.Also the measurement of parallelism was within the accepted tolerance (tol.0 ± 0,02 mm).In the next step the valve could be tested positively for permeability.In order to investigate the suspicion of a malfunction, we carried out a computer-controlled measurement on the progav valve.The progav valve was measured at an opening pressure of 11 cmh20 in a horizontal position.With a measured value of 8,20 cmh20 in the reference flow level of 20 ml/h the valve operates within the accepted tolerance.Additionally, we tested the adjustability as well as the brake functionality and brake force of the progav valve.The valve was adjustable to all settings.The braking force and brake function were also within tolerance.Finally, we have dismantled the valve.Inside the valve, we have found visible build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of occlusion and malfunction.At the time of our investigation, the valve met all test criteria.Nevertheless, we suspect that the deposits found inside the valve could have led to the functional impairment in the past.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/ADJ.DP.UNIT A.CONTROL RES.
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9843176
• MDR Text Key: 183758421
• Report Number: 3004721439-2020-00058
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K120559
• 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: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2021
• Device Model Number: FV770T
• Device Catalogue Number: FV770T
• Device Lot Number: 20032006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• 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: 24 YR
• Patient Weight: 100