MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE PLUS SYS W/CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX824T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: during the investigation, bloody residues were found on the valves.Permeability test: a permeability test has shown that all valves are permeable.During the permeability test bloody liquid were flushed out.Computer controlled test: to investigate the claim of malformation, 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 position.The results show that the valves do not operate within the permissible tolerance in their respective relevant position.Adjustment test: during the adjustment test it was determined that the progav 2.0 but not the m.Blue is adjustable in all pressure ranges.Braking force and brake function test: the brake function test has shown that the brake function works as expected for both valves; however, the braking force can only be measured for the progav 2.0 due to the non-adjustability of the m.Blues; this is within tolerance.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: we would like to point out in advance that the product sent in was not immersed in liquid at the time of delivery.Testing valves sent in dry is only of limited value.The product properties can be influenced by dry residues of cerebrospinal fluid or blood.Nevertheless, we examined the valve.Based on our investigation results, we were able to determine a slowed outflow and non-adjustability on the m.Blue, as well as an accelerated outflow on the progav 2.0.The deposits visible in the valves may have led to the malfunctions.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.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 or Problem Description
It was reported that an m.Blue plus (#fx824t) was implanted during a procedure performed on (b)(6) 2023.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: 65 years.Weight: 54 kgs.Height: 160 cm.Gender: female.

• Brand Name: M.BLUE PLUS SYS W/CONTROL RESERVOIR
• Common Device Name: 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: 19827676
• Report Number: 3004721439-2024-00208
• Device Sequence Number: 8612406
• Product Code: JXG
• UDI-Device Identifier: 04041906504830
• UDI-Public: 4041906504830
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2024

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
• Operator of Device: Health Professional
• Device Model Number: FX824T
• Device Catalogue Number: FX824T
• Device Lot Number: 20061690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 54 KG