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

Model Number	FX844T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: during the investigation, scratches on the outer housing of the valves, but no significant deformations or damage were determined permeability test: a permeability test has shown that the m.Blue has a blockage while the progav 2.0 is permeable.During the permeability test bloody liquid were flushed out.Computer controlled test: to investigate the claim of under-drainage, 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 progav 2.0 operates within the permissible tolerance in horizontal position.Because the m.Blue is not permeable, a computer controlled test is not possible adjustment test: during the adjustment test it was determined that the m.Blue but not the progav 2.0 is adjustable in all pressure ranges.Braking force and brake function test: the brake functionality test of the m.Blue has shown that the brake function operates as expected; and the braking force is within the given tolerances.The brake functionality test of the progav 2.0 has shown the brake function operates as expected; however, the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection: after dismantling of the valves, deposits were found in both valves.Results: based on the investigation results, the m.Blue was found to be blocked and the progav 2.0 was found to be non-adjustable.The deposits visible in the valves are the cause of the malfunctions mentioned.Deposits caused by substances naturally present 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 (#fx844t) was implanted.According to the complainant, the shunt system showed an under-drainage.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: 23 years.Gender: male.

• Brand Name: M.BLUE PLUS SYS W/SPRUNG 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: 19760389
• Report Number: 3004721439-2024-00197
• Device Sequence Number: 12384978
• Product Code: JXG
• UDI-Device Identifier: 04041906504878
• UDI-Public: 4041906504878
• 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 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): 07/17/2024

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: FX844T
• Device Catalogue Number: FX844T
• Device Lot Number: 20064760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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: 23 YR
• Patient Sex: Male