MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 W/SA2.0 25 & DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number FX649T

Device Problem Infusion or Flow Problem (2964)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Date 08/09/2019

Event Type  Injury  

Manufacturer Narrative

Height: (b)(6).When additional information becomes available a follow up report will be submitted.

Event Description

It was reported that the valve was blocked and under draining.The reporter indicated that a 2 month 18 day post operative valve is blocked and under draining.Additional details of the event have not been provided.

Manufacturer Narrative

Investigation.Visual inspection: scratches on the outer housing of the valves were observed through the visual inspection.No significant deformations or damage were detected.Permeability test: a permeability test has indicated that the progav 2.0 valve has a blockage and that the shunt assistant 2.0 is permeable.Adjustment test: the progav 2.0 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 is fully operational and the braking force is within the given tolerances.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.Because the progav 2.0 valve is not permeable, a computer controlled test was not possible.The shunt assistant 2.0 operates within the accepted tolerance.Results: first we performed a visual inspection of the progav 2.0 shunt system.No significant deformations or damage of the valves were detected during the visual inspection.Next we tested the permeability and opening pressure of the valves.The progav 2.0 valve was not permeable, therefore the claim of under-drainage could be confirmed.The shunt assistant 2.0 was permeable and operating within specifications.Additionally, we tested the adjustability as well as the brake functionality and brake force of the progav 2.0 valve.The valve operated as expected and met all specifications.Finally, we have dismantled the valves.Inside the progav 2.0 we have found slight build-up of substances (likely protein) inside the shunt assistant 2.0 we have found no visible deposits.Based on our investigation, we confirm that the shunt system was operating in an under-drainage state at the time of our investigation, because of the blockage of the progav 2.0.This is likely due to the deposits observed inside the progav 2.0.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 2.0 W/SA2.0 25 & DISTAL CATHETER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8962327
• MDR Text Key: 156572882
• Report Number: 3004721439-2019-00213
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: FX649T
• Device Catalogue Number: FX649T
• Device Lot Number: 20037340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 70