MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS SA2.0 25 & PED.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number FX597T

Device Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)

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

Event Date 09/02/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: visual inspection: a deformation of the outer housing of the progav 2.0 valve was observed through the visual inspection.Permeability test: a permeability test has shown that both valves are permeable.Adjustment test: the progav 2.0 valve was tested and is adjustable to all specified pressures; however, the pressure settings could not be maintained.Braking force and brake function test the brake functionality test has shown that the brake function did not operate as expected.The results indicate that the rotor no longer performs as required.The measurement of the brake function as well as the braking force could additionally confirm that the valve characteristics were influenced by the deformation.The rotor is defect.The valve adjusts itself and does not maintain the pressure settings.Results: first, we performed a visual inspection of the progav 2.0 shunt system.Significant scratches and damage to the outer housing of the progav 2.0 valve were observed through the visual inspection.Next, we tested the permeability.Both valves were shown to be permeable.Additionally, we tested the adjustability as well as the brake functionality and brake force of the progav 2.0 valve.The valve was adjustable to all settings.However, the brake functionality was not operational, however due to the inability of the valve to hold a set pressure; it was not possible to measure the brake force.Finally, we have dismantled the progav 2.0.There were no visible deposits observed inside the valve.Based on our investigation, we confirm that the progav 2.0 valve has adjustability issues at the time of our investigation.The cause of the deformation of the progav 2.0 valve and the resultant defect of the rotor could not be determined through our investigation.Significant outside pressure, for example by too much force from the progav adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve.As described in the enclosed instructions for use, it is recommended to change the pressure level with the progav 2.0 adjustment instrument set or the progav check mate.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 (b)(4).

Event Description

It was reported that the valve was not adjustable.The reporter indicated that a 27 day post-operative valve is not adjustable and required explantation.Additional details of the event are not available.

• Brand Name: PROGAV 2.0 SYS SA2.0 25 & PED.PRECHAMBER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9147161
• MDR Text Key: 160935110
• Report Number: 3004721439-2019-00244
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX597T
• Device Catalogue Number: FX597T
• Device Lot Number: 20042498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR