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

Model Number	FX824T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/31/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that a m.Blue plus (#fx824t) was implanted during a procedure performed on (b)(6) 2021.According to the complainant, the shunt system caused an underdrainage and had adjustment difficulties.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.Age: 6 years, 3 months height: 110 cm weight: 18 kg gender: female.
Event or Problem Description
The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Visual inspection: during the investigation, scratches on the outer housing of the m.Blue.Permeability test: a permeability test has shown that both valves are permeable.Computer controlled test: to investigate the claim of under-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 progav 2.0 and then m.Blue operates within the accepted tolerances in the horizontal position, while the m.Blue does not operates within the specified tolerances in the vertical position at the opening pressure of 20 cmh2o.An accelerated outflow of m.Blue could be determined.Adjustment test: during the adjustment test it was determined that the m.Blue but not the progav 2.0 is adjustable in all pressure ranges.Braking force and brake function test: the brake functionality test has shown that: the m.Blue: the brake function operates as expected; and the braking force is within the given tolerances.The progav 2.0: the brake function operates as expected; however, the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection: after dismantling of the valves, deposits were found inside.Results: first of all, we would like to point out that the m.Blue was returned with an opening pressure of 0 cmh2o.In this case, we also examine the valve with the opening pressure at the time of delivery to the customer.Thus, we also examined the m.Blue at 20 cmh2o.The investigation showed that the m.Blue works in the vertical position at the opening pressure of 0 cmh2o and in the horizontal position in the tolerance, but not in the vertical position at the opening pressure of 20 cmh2o, where we could see an accelerated outflow.Furthermore, we can determine that the progav 2.0 is non-adjustable.The reason for the malfunctions found in the valves is the deposits found in both valves.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.

• Brand Name: M.BLUE PLUS SYS. WITH 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: 20320897
• Report Number: 3004721439-2024-00297
• Device Sequence Number: 12763743
• Product Code: JXG
• UDI-Device Identifier: 04041906504830
• UDI-Public: 4041906504830
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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: 01/20/2026
• Device Model Number: FX824T
• Device Catalogue Number: FX824T
• Device Lot Number: 20051435
• 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: 09/04/2024
• 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: 01/25/2021
• 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: 6 YR
• Patient Sex: Female
• Patient Weight: 18 KG