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 Codes	Obstruction of Flow (2423); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: during the investigation, no significant deformations or damage of the valves were determined permeability test: a permeability test has shown that the m.Blue has a blockage while the progav 2.0 and the pedi.Control reservoire 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 operates within the permissible tolerance in the horizontal position.Because the m.Blue is not permeable, a computer controlled test is not possible adjustment test: during the adjustment test it was determined that the progav 2.0 but not 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 of the progav 2.0 operates as expected; and the braking force is within the given tolerances.The braking function also works as expected with the m.Blue; however, the braking force cannot be measured because the valve is not adjustable.Internal inspection: after dismantling of the valves, deposits were found in both valves, the pedi control reservoir was inconspicuous results: in advance, we would like to point out that the product sent in was not inserted in liquid at the time of delivery.Dried deposits can influence the function of the products, which can affect the results.Despite this, we have examined the valve.Based on our investigation results, we can determine a blockage and a non-adjustability at the m.Blue.The visible deposits in the valve have led to the functional impairment.Furthermore, we can determine visible deposits in the progav 2.0.These deposits did not affect the specifications at the time of the investigation.The pedi.Control reservoir was found to be within specifications.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 plus (#fx819t) was implanted during a procedure performed on (b)(6) 2024.According to the complainant, the shunt system caused an underdrainage and had adjustment difficulties.The patient underwent a revision procedure on (b)(6) 2024.The complained product was sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.

• 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: 20878444
• Report Number: 3004721439-2024-00391
• Device Sequence Number: 7851486
• Product Code: JXG
• UDI-Device Identifier: 04041906504823
• UDI-Public: 4041906504823
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 12/09/2024

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: 20076844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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: 3 YR
• Patient Sex: Female
• Patient Weight: 18 KG