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

Model Number FX431-T

Device Problem Free or Unrestricted Flow (2945)

Patient Problems Unspecified Infection (1930); Hydrocephalus (3272)

Event Type  Injury  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported that the po infection after implantation.Fx431-t and fv303t shunts were used in combination.Patients were implanted shunts for ventriculoperitoneal drainage.After implantation, infection occurred in the patient's brain.Then withdrew the shunt pipe.

Manufacturer Narrative

(b)(6).Manufacturing site evaluation: the shunt system was manufactured by a qualified employee; deviations during assembly did not occur.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Investigation - the shunt system was received dry; it was connected to a paedigav valve (reported separately).No significant deformations or damage of the valves were detected during the visual inspection.It was noted that the ventricular catheter was not properly connected to the control reservoir.Permeability test- this test has shown that the valve has a blockage and that the catheter was permeable.Additionally, the control reservoir was able to be pumped and filled with liquid and then drain the liquid as well.Adjustment test - this has shown that the valve was adjustable to all specified pressures.Braking force and brake function test - this has shown that the brake function is fully operational and the braking force is within the given tolerances.Results - it should be noted that the shunt system was received dry.The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the shunt system to the best of our abilities.After the tests, we have dismantled the valves.Inside, we found a slight build-up of substances (likely protein).Based on our investigations, we confirm the presence of occlusion in the system at the time of investigation.This is likely due to the deposits observed inside the valves.As described in our literature, the problem encountered is one of the known, inevitable risks of hydrocephalus 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 SYSTEM WITH CONTROL RESERVOIR
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam, 14469 ; GM 14469
• MDR Report Key: 8610037
• MDR Text Key: 145085920
• Report Number: 3004721439-2019-00119
• 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: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2022
• Device Model Number: FX431-T
• Device Catalogue Number: FX431-T
• Device Lot Number: 20035304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/20/2019
• Device Age: 18 MO
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 60