MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA25 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number FX428T

Device Problem Mechanical Problem (1384)

Patient Problem Hydrocephalus (3272)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

Visual inspection: during the investigation, scratches and organic deposits on the outer housing of the valves, but no significant deformations or damage were determined.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to investigate the opening pressure of the valves, they were tested with 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 operates within the accepted tolerance in the horizontal position.The shuntassistant does not operate within the specified tolerances in the vertical position.An accelerated outflow of shuntassistant 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 operates as expected 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 deposits in the shunt system more visible, they were colored using a staining solution.Results: based on our investigation results, we can determine visible deposits in the progav 2.0.The deposits visible in the valve had no effect upon the specifications at the time of the examination.The adjustment difficulties complained about could not be confirmed.Based on our test results, we can determine an accelerated outflow at the shuntassistant.The deposits visible in the valve may have led to the change in flow rate.Deposits caused by substances naturally present in the patient's 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 organic material can affect the integrity of the valve.The cathters and the sprung reservoir met the specification.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 (#fx428t) was implanted during a procedure performed on (b)(6) 2015.According to the complainant, the shunt system showed adjustment difficulties.The patient underwent a revision procedure performed on (b)(6) 2024.The complainant device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 41 years, 5 months.Weight: 94 kgs.Height: 173 cm.Gender: female.

• Brand Name: PROGAV 2.0 SYS W/SA25 A.SPRUNG RESERVOIR
• 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: 18981771
• MDR Text Key: 338661313
• Report Number: 3004721439-2024-00062
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906136987
• UDI-Public: 4041906136987
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2024

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 Expiration Date: 06/26/2020
• Device Model Number: FX428T
• Device Catalogue Number: FX428T
• Device Lot Number: 20027032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 94 KG