MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 0 VALVE; HYDROCEPHALUS MANAGEMENT

Model Number	FX800T
Medical Device Problem Codes	Obstruction of Flow (2423); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Event or Problem Description
The adverse event is filed under aic reference (b)(4).It was reported that an m.Blue (#fx800t) was implanted during a procedure performed on an unspecified date.According to the complainant, the shunt system caused an underdrainage.The patient underwent a revision procedure on an unspecified date.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information or the investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The adverse event is filed under aic reference xc 100039186 cc 400709546.Additional information: h6 codes updated.Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for the available lot number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: M.BLUE 0 VALVE
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ,; GM 14469,
• MDR Report Key: 22104776
• Report Number: 2916714-2025-00022
• Device Sequence Number: 7122705
• Product Code: JXG
• UDI-Device Identifier: 04041906504397
• UDI-Public: (01)04041906504397(11)240430(17)290428(10)20075028
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/16/2025
• Report Date (Section F): 05/29/2025

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: 20075028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/28/2025
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/16/2025
• 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: Unknown
• Date Report Sent to FDA: 05/29/2025