MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 5 VALVE; HYDROCEPHALUS MANAGEMENT

Model Number	FX801T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a m.Blue (#fx801t) was implanted.According to the complainant, the valve caused an underdrainage.The patient underwent a revision procedure.The complained the m.Blue, + a pediatric prechamber was sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Visual inspection: during the investigation, no significant deformations or damage of the valves was determined.Permeability test: a permeability test has shown that all components are permeable.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 valve is tested in both the horizontal as well as the vertical positions.The results show that the m.Blue is not operating within the acceptable tolerance in either position.An accelerated outflow of m.Blue could be determined.Adjustment test: the m.Blue valve 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 valve, deposits were found in m.Blue while no deposits were found in the ped.Prechamber.Results: based on our investigation results, we can determine an accelerated outflow at m.Blue.The deposits visible in the valve have led to the change in flow rate.Deposits of natural substances found 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.Furthermore, we can determine that the pediatric prechamber works within its specifications.We can exclude a defect at the time of release.The valve 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.

• Brand Name: M.BLUE 5 VALVE
• 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: 21034326
• Report Number: 3004721439-2024-00402
• Device Sequence Number: 9087341
• Product Code: JXG
• UDI-Device Identifier: 04041906504403
• UDI-Public: 4041906504403
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/30/2024

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: FX801T
• Device Catalogue Number: FX801T
• Device Lot Number: 20064591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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: 14 YR
• Patient Sex: Male