MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 WITH SA25 AND DISTAL CATHETER; HYDROCEPHALUS VALVES

Model Number FX421T

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 08/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Implant date: unknown.Pending further information.

Event Description

It was reported by the healthcare professional to the company sales representative "the valve was removed due to infection after implant.When checking the product after removing, the leakage seemed to occur, however the position of leakage was not found.Additional information: the patient got inflammation, possibly caused by the leakage.Therefore, the revision surgery was done.The patient does not have infection.All med watch submissions related to this report are: 3004721439-2018-00235 (this report); 3004721439-2018-00236.

Manufacturer Narrative

We received the shunt system in a returnkit.The valve was submerged in an unknown liquid.The progav2.0 valve was at a pressure setting of 0.The first step of our investigation is an optical inspection.We found scratches on the valve housing but did not detect any obvious deformations or other abnormalities.Ligature thread was found on the catheter.The ligature thread is not a product from miethke gmbh & co.Kg.To find out if the catheter had a hole, we performed a visual investigation under a microscope.No damage to the catheter was detected.To proof the penetrability of the valve, we carried out a permeability test.This test was carried out at a hydrostatic pressure difference of approximately 20-30 cmh2o in the direction of flow.The test results showed that both the progav2.0 valve and the catheter were penetrable.Furthermore, when flushing the catheter with test fluid, we have found no leakage.Adjustment tests are carried out with the standard progav2.0 check-mate and measurement tool.The valve is adjusted from 0 to 20 cmh2o and down again in increments of 5 cmh2o.The test showed that the valve is adjustable to all settings.To measure the braking force, we have investigated the 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.The investigation of the braking force has shown that the brake function is fully operational.Based on our investigation results we cannot confirm a blockage of the shunt system or leakage of the catheter.We suspect that the deposits of protein found in the paedisa valve and on the spout could have led to a blockage of the shunt system in the past.No further actions are required.

• Brand Name: PROGAV 2.0 WITH SA25 AND DISTAL CATHETER
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 7895295
• MDR Text Key: 120921207
• Report Number: 3004721439-2018-00235
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX421T
• Device Catalogue Number: FX421T
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/10/2018
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/20/2018
• Supplement Dates Manufacturer Received: 11/05/2018
• Supplement Dates FDA Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention