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

Model Number	FX819T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/07/2024
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 both valves are permeable.Computer controlled test: to investigate, 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 progav 2.0 operates within the accepted tolerances in the horizontal position, while the m.Blue does not operates within the specified tolerances in the horizontal position.An slower outflow of the m.Blue could be determined.Adjustment test: during the adjustment test it was determined that both valves are 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 valves, deposits were found in both valves.Results: based on our investigation results, we can determine a slower outflow in the m.Blue.The determined deposits can be named as the cause for the slower outflow.Organic matter in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.Furthermore, we can determine deposits in the progav 2.0.The deposits had no affect to the technical properties at the time of the investigation.The cause of the aforementioned functional impairment is not known to us at the time of the examination.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from (b)(6).No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that an m.Blue plus (#fx819t) was implanted during a procedure performed on (b)(6) /2024.According to the complainant, the shunt system caused an overdrainage and an underdrainage.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 34 years height: 170 cm weight: 70 kg gender: female.

• Brand Name: M.BLUE PLUS SYS W/PED.CONTROL 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: 20225205
• Report Number: 3004721439-2024-00283
• Device Sequence Number: 3504919
• Product Code: JXG
• UDI-Device Identifier: 04041906504823
• UDI-Public: 4041906504823
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/16/2024

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 Model Number: FX819T
• Device Catalogue Number: FX819T
• Device Lot Number: 20073692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (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: 34 YR
• Patient Sex: Female
• Patient Weight: 70 KG