MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 10 VALVE; HYDROCEPHALUS MANAGEMENT

Model Number	FX802T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/27/2023
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
Minor update to b5 (spelling).It was reported to aesculap inc.That an m.Blue 10 valve (part # fx802t) was implanted during a procedure performed on an unknown date.According to the complainant, the valve was not able to be externally adjusted.The membrane of the valve seems to be stuck in the depressed position.The valve was not able to be felt under the patient's skin, and no audible click was present.Additionally, the valve setting remains the same after attempting to reprogram.The clinic is confident that the valve is implanted correctly, based on x-rays, the reprogramming tools, and since the patient has not experienced any adverse effects.The patient will undergo a revision surgery; however, the surgery date has not been provided.The complaint device has not yet been returned to the manufacturer for evaluation.The adverse event is filed under aic reference (b)(4).
Event or Problem Description
Investigation complete.
Additional Manufacturer Narrative
Additional information: patient information (a2, a3, a4) relevant history (b7), explantation date (d6b), device available evaluation (d9) investigation: visual inspection during the investigation, scratches on the outer housing of the valve, but no significant deformation or damage was determined.Permeability test: a permeability test has indicated that the valve has a blockage.Computer control test because the valve is not permeable, a computer control test is not applicable.Adjustment test the m.Blue was tested and is not adjustable.Braking force and brake function test: the brake functionality test has shown that the brake function is operational.The braking force cannot be measured due to the non-adjustability of the valve.Internal inspection : after dismantling of the valve, deposits were found in the m.Blue.Result : based on our investigation results, we can determine a blockage and a non- adjustability at the valve.The determined deposits can be named as the cause for the functional deviations.Ortganic deposits in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.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 10 VALVE
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 17975522
• Report Number: 2916714-2023-00100
• Device Sequence Number: 2453836
• Product Code: JXG
• UDI-Device Identifier: 04041906504410
• UDI-Public: 4041906504410
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023
• Report Date (Section F): 10/20/2023

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: FX802T
• Device Catalogue Number: FX802T
• Device Lot Number: 20062188
• 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: 09/27/2023
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2023
• 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: 10/20/2023
• Supplement Report FDA Received Date: 11/20/2023
• 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 Age: 8 MO
• Patient Sex: Male
• Patient Weight: 8 KG
• Date Report Sent to FDA: 10/20/2023