MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 10 SYS W/PED.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX827T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: during the investigation, scratches on the outer housing of the valves, but no significant deformations or damage were determined permeability test: a permeability test has shown that the m.Blue has a blockage while the pedi sprung reservoir and the peritoneal catheter are permeable.Computer controlled test: due to the blockage, no measurement could be made on the computer test bench.Adjustment test: during the adjustment test it was determined that the m.Blue 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; and the braking force is 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 clogging of the m.Blue.The visible deposits in the valve have led to the functional impairment.Furthermore, based on our examination results, we cannot detect any functional deviations or other anomalies on the peritoneal catheter and pedi.Sprung reservoir.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 an m.Blue shunt system (#fx827t) was implanted during a procedure performed on (b)(6) 2024.According to the complainant, the shunt system showed an under-drainage/blockage.The patient underwent a revision procedure performed on (b)(6) 2024.The complainant device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 73 years.Weight: 75 kgs.Height: 175 cm.

• Brand Name: M.BLUE 10 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: 20320843
• Report Number: 3004721439-2024-00296
• Device Sequence Number: 12798688
• Product Code: JXG
• UDI-Device Identifier: 04041906504618
• UDI-Public: 4041906504618
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2024

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
• Device Model Number: FX827T
• Device Catalogue Number: FX827T
• Device Lot Number: 20075654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 75 KG