MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 2.0 30; HYDROCEPHALUS MANAGEMENT

Model Number FX644T

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hydrocephalus (3272)

Event Type  Injury  

Manufacturer Narrative

Visual inspection: during the investigation, scratches on the outer housing of the valves, but no significant deformations or damage was determined.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to check the function of the valve, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical positions.The results show that the progav 2.0 is operating within the accepted tolerance in the horizontal position.The shuntassistant 2.0 is operating not within the specified tolerances in the vertical position.An accelerated outflow of shuntassistant 2.0 could be determined.Adjustment test: the progav 2.0 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.Internal inspection: after dismantling of the valves, deposits were found in both valves.To make the proteins / deposits in the shunt system more visible, they were colored using a staining solution.Results: based on our investigation results, we can determine an accelerated outflow on the shuntassitant 2.0.The deposits visible in the valve may have led to the change in the flow rate.The visible deposits in the progav 2.0 do not impair the functionality of the valve.Deposits caused by natural substances in the body, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of proteins can impair the integrity of the valve.Unfortunately, it is not possible for us to examine the shunt system for an infection, so we cannot confirm this.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.No further regulatory actions are required from our point of view.

Event Description

It was reported that a progav 2.0 shunt system (#fx644t) was implanted during a procedure performed on unknown according to the complainant, the shunt showed an infection.The patient underwent a revision procedure performed on unknown.The complainant device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 13 years.Weight: 20 kgs.Height: 120 cm.Gender: female.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 2.0 30
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 18172958
• MDR Text Key: 328561305
• Report Number: 3004721439-2023-00349
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906502027
• UDI-Public: 4041906502027
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX644T
• Device Catalogue Number: FX644T
• Device Lot Number: 20062737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2022
• 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: 13 YR
• Patient Sex: Female
• Patient Weight: 20 KG