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	03/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is filed under aic reference xc (b)(4) cc (b)(4).According to the event description: mblue 0 had to be revised becuase it was completely occluded.The valve was explanted and was shown to have no flow.

• 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: 24911688
• Report Number: 2916714-2026-00014
• Device Sequence Number: 13071893
• Product Code: JXG
• UDI-Device Identifier: 04041906504397
• UDI-Public: (01)04041906504397(11)250310(17)300309(10)20081254
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026
• Report Date (Section F): 04/17/2026

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: 20081254
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/28/2026
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2026
• 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: 04/17/2026
• Supplement Report FDA Received Date: 05/08/2026
• 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: 04/17/2026