MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 5 SYS W.PED.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX816T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a m.Blue (part#: fx816t) was implanted during a procedure performed in 2019.According to the complainant, the valve caused an under- drainage and had adjustment difficulties.The patient underwent a revision procedure.While removing, the lid was loosened from the valve.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 4 years, 7 months, gender: male.
Additional Manufacturer Narrative
Investigation: visual inspection: the visual inspection revealed the following: deposits in the area of the weight, bent small spring, brake spring missing, damage to the lid/ cover and housing.Together with the information about the return from the clinic, another picture of the return before repackaging in the returnkit was submitted via email.Here, further deposits and the brake spring are visible.Permeability test: not applicable, as the valve is already open.Computer controlled test: not applicable, as the valve is already open.Adjustment test: not applicable, as the valve is already open.Braking force and brake function test: not applicable, as the valve is already open.Internal inspection : the valve was already open.Results: we would like to point out in advance that the product sent in was already in an opened state at the time of delivery.Based on our examination results, we can determine deposits, a bent spring and damage to the lid and housing.The deposits found can be named as the cause of the blockage/underdrainage.Based on the submitted picture via email, the visible deposits can also be named as the cause for the adjustment difficulties.Deposits caused by substances naturally present in the body, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.How the valve opened remains unclear.With the verified data of the final inspections before shipment, as well as the functionality over 4 years after the implantation, we can exclude a deviation in the performance of the product.Loosening of the lid is only possible under extreme circumstances (non-physiological conditions) or in connection with auxiliary means.All valves are verified for conformity according to iso7197 for shunts.A detachment of the lid under physiological conditions can be excluded.We can exclude a defect at the time of release.The valve 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 5 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: 17375289
• Report Number: 3004721439-2023-00195
• Device Sequence Number: 3784691
• Product Code: JXG
• UDI-Device Identifier: 04041906504526
• UDI-Public: 4041906504526
• 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 Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2023

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: 05/09/2024
• Device Model Number: FX816T
• Device Catalogue Number: FX816T
• Device Lot Number: 20042141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2019
• 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: 4 YR
• Patient Sex: Male