MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	FX800T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a m.Blue 0 valve (part# fx800t) was implanted was implanted (b)(6) 2025.According to the complainant the patient was adjusted on (b)(6) 2025.Reportedly the surgeon dropped the patient to 3 and 3 and still won't drain vents well even though previously had high icp.Patient was taken in for revision surgery.After explanting the m.Blue 0 valve surgeon reported that the valve was occluded and was removed/replaced with another m blue 0 which was set to 5.The patient had cerebrospinal fluid (csf) cultures grow rare staff after four days.On (b)(6) 2025 the surgeon had reported: "same thing happened again and again, the m.Blue was completely blocked.It's set at 0, don't know what's happening.I removed shunt and placed evd, but it looks like mechanical failure to me.At least for this patient, she will get another manufacturer's valve and i need a clear explanation of what is going on.If it's a programming problem, we need educated.If it's mechanical, we deserve a refund as does the patient." the adverse event is filed under aic reference xc (b)(4).
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 the m.Blue is permeable.Computer controlled test: to investigate the claim of under-drainage / blockage, 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 operates within the accepted tolerance in both positions.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, no deposits were found in m.Blue results: based on our investigation results, we cannot determine functional deviations or other abnormalities in the product.The product operated within all specification.The examination of the return has been completed with the drafting of this report.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.
Event or Problem Description
It was reported that an m.Blue (0) valve (#fx800t) was implanted on (b)(6) 2025.According to the complainant, the valve caused an under-drainage.The patient underwent a revision procedure on (b)(6) 2025.No patient complications were reported as a result of the revision procedure.The complained product was sent to the manufacturer for investigation.

• Brand Name: M.BLUE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 21483124
• Report Number: 2916714-2025-00005
• Device Sequence Number: 14442191
• Product Code: JXG
• UDI-Device Identifier: 04041906504397
• UDI-Public: (01)04041906504397(11)241121(17)291119(10)20078924
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025
• Report Date (Section F): 02/27/2025

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: FX800T
• Device Catalogue Number: FX800T
• Device Lot Number: 20078924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/07/2025
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 03/13/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 02/27/2025