MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS PED.W/SA 20 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number FV441T

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/24/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there was pressure adjustment failure.The reporter indicated that the product was implanted on the patients birth in (b)(6) 2015.Pressure adjustment failure was seen in (b)(6) 2017, but since no serious symptoms were observed, the doctor monitored the patients condition.However, the patients symptoms did not improve, and the device was replaced with (b)(4) in (b)(6) 2019.Patient information was not provided.Additional information has been requested.

Manufacturer Narrative

Investigation: visual inspection: scratches on the outer housing of the progav and yellow deposits on the catheters were observed through the visual inspection.No significant deformations or damage were detected.The progav valve housing was subsequently measured and indicated no presence of a deformation.The housing measured at -0.017 mm, inside the tolerance of 0 ± 0.02 mm.Permeability test: a permeability test has shown that the shuntsystem is permeable.Adjustment test: the progav 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 breaking force required was not within the specified tolerances.Results: first, we performed a visual inspection of the progav shunt system.No significant deformations or damage of the valves were detected during the visual inspection.Next, we tested the permeability of the shunt system.Both valve were shown to be permeable.Additionally, we tested the adjustability as well as the brake functionality and brake force of the progav valve.The valve operated as expected, however the brake force was outside of tolerance.All other specifications were met.Finally, we have dismantled the progav valve.Inside the progav we have found build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of non-adjustability.At the time of our investigation, the progav was able to be adjusted to all specified settings.However, it is possible that the deposits observed inside the valve could have caused the 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.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: PROGAV SYS PED.W/SA 20 A.PRECHAMBER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9572036
• MDR Text Key: 188573748
• Report Number: 3004721439-2020-00005
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K103003
• 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: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FV441T
• Device Catalogue Number: FV441T
• Device Lot Number: 30100334
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR