MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE PLUS SYS W/PED.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX829T
Medical Device Problem Codes	Infusion or Flow Problem (2964); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a m.Blue plus (#fx829t) was implanted during a procedure.According to the complainant, the shuntsystem caused an overdrainage.The patient underwent a revision procedure.The complainant device will be returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Traceability of the production data was carried out.No deviation was determined.The investigation on the product is still pending.Should relevant additional information/investigation results become available, an supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Visual inspection: during the investigation, scratches on the outer housing were determined permeability test: a permeability test has shown that the valve is permeable.Computer controlled test: to investigate the claim of over-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical position.The results show that the valve operates in the permissible tolerance in the vertical position but noch in the horricontal position.A slower outflow of m.Blue could be determined.Adjustment test: during the adjustment test it was determined that the valve is adjustable in all pressure ranges.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected; however, the braking force required was not within the given tolerances.Internal inspection: after dismantling of the valve, deposits were found inside.Results: based on our investigation results, we can determine a reduced outflow in the vertical position at the valve, furthermore, the braking force is not within the tolerance.The visible deposits in the valve have led to the functional impairment.Deposits caused by substances naturally present in the patient's 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 organic material can affect the integrity of the valve.We can exclude a defect at the time of release.The shunt system 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 a m.Blue plus (#fx829t) was implanted during a procedure on (b)(6) 2022.According to the complainant, the shunt system caused an overdrainage and adjustment difficulties.The patient underwent a revision procedure on (b)(6) 2024.The complainant device has be returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.

• Brand Name: M.BLUE PLUS SYS W/PED.SPRUNG RESERVOIR
• 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: 20320938
• Report Number: 3004721439-2024-00306
• Device Sequence Number: 8183617
• Product Code: JXG
• UDI-Device Identifier: 04041906504847
• UDI-Public: 4041906504847
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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 Expiration Date: 11/04/2025
• Device Model Number: FX829T
• Device Catalogue Number: FX829T
• Device Lot Number: 20050445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• 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: 11 YR
• Patient Sex: Female
• Patient Weight: 50 KG