MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 2.0 35; HYDROCEPHALUS MANAGEMENT

Model Number	FX105T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shuntassistant 2.0 (part#: fx105t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the shunt system was believed to be operated different, overdrainage (in vertical position) and blocked (in horizontal position).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: 52 years.Height: 153 centimeters (cm).Weight: 59 kilograms (kg).Gender: female.
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: according to our results, we can determine an accelerated outflow in the vertical position.Additionally (because the information on the questionnaire) the shuntassistant 2.0 was tested according to standard procedure in the horizontal position of the valve.The results indicated that at a reference flow of 20 ml/h in the horizontal position, the shuntassistant 2.0 had a pressure of 0.36 cmh2o.This is within the specified tolerance of 0 - 4 cmh2o.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 the valve is dismantled, it is possible to see a large part of the inner.But there are certain parts of the valve which are not visible.Deposits may be present there which impair the function of the valve.To make possible invisible proteins/deposits visible, the valve was submerged in a coloring solution.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 vertical position at the time of our investigation.Detected deposits could be the cause of the accelerated outflow.Endogenous substances 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 35
• 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: 16028924
• Report Number: 3004721439-2022-00389
• Device Sequence Number: 14821843
• Product Code: JXG
• UDI-Device Identifier: 04041906501617
• UDI-Public: 4041906501617
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2022

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: FX105T
• Device Catalogue Number: FX105T
• Device Lot Number: 20055873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2021
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 59 KG