MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 2.0 30; HYDROCEPHALUS MANAGEMENT

Model Number	FX104T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shuntassistant 2.0 (#fx104t) was implanted in combination with a m.Blue during a procedure performed on (b)(6) 2023.According to the complainant, the valves were believed to be operated in overdrainage.The patient underwent a revision procedure.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 34 years.Height: 160 centimeters (cm).Weight: 52 kilograms (kg).Gender: female.Same event/ patient as medwatch#3004721439-2023-00138.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: no abnormalities.Permeability test: the test showed that the shuntassistant 2.0 is permeable.Computer control test: the computer control test showed the opening pressure of the shuntassistant 2.0, at a reference flow rate of 20 ml/h in a vertical position of the valve, to be 24.93 cmh2o.This is not within the specified tolerance of 30 +4/-2 cmh2o.An applied pressure of 30 cmh2o, with the device in the vertical position is expected to have a resultant pressure of 30 +4/-2 cmh2o.The measurement showed a tendency to an accelerated outflow.Internal inspection of product: in order to verify whether the investigated valve was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, the valve is finally opened with a special tool.After dismantling of the valve, no deposits were found in shuntassistant 2.0.When opening valves, it is possible to see a large part of the interior, but there are also areas that cannot be inspected and where there may be deposits that can affect the function of the valve.For more detailed visibility for possible deposits, the shuntassistant 2.0 were submerged in a coloring solution.After the coloring deposits were visible.Results: for the sake of thoroughness and transparency, we would like to point out that a permeability test was already carried out after the revision at the hospital.Based on our investigation results, we have determined that there was an accelerated outflow in the valve at the time of our investigation.Detected deposits could be the cause of the accelerated outflow.Existing deposits in the csf can temporarily impair the function of the valve and is described as concomitant symptoms in hydrocephalus therapy.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.

• Brand Name: SHUNTASSISTANT 2.0 30
• 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: 16989421
• Report Number: 3004721439-2023-00139
• Device Sequence Number: 6343757
• Product Code: JXG
• UDI-Device Identifier: 04041906501600
• UDI-Public: 4041906501600
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/23/2023

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 Model Number: FX104T
• Device Catalogue Number: FX104T
• Device Lot Number: 20062017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• 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: 34 YR
• Patient Sex: Female
• Patient Weight: 52 KG