MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 20; HYDROCEPHALUS MANAGEMENT

Model Number	FV251T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shuntassistant (part # fv251t) was implanted during a procedure performed on (b)(6) 2021.According to the complainant, the shunt system was believed to be operated in overdrainage.The patient underwent a revision procedure on an unknown date.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Same event as medwatch mdr id 3004721439-2022-00103.
Additional Manufacturer Narrative
Investigations: visual inspection the following observations were made during the visual inspection: no abnormalities detected.Permeability test: the test showed that the shuntassistant is permeable.Computer control test: the computer-controlled test showed the opening pressure of the shuntassistant, at a reference flow rate of 20 ml/h in a vertical position of the valve, to be 19,20 cmh2o.This is within the specified tolerance of 20 cmh2o +4 / -2 cmh2o.Internal inspection of product: after dismantling of the valve, deposits were found in shuntassistant.Results: based on our examination results, we can detect deposits in the outlet of the shuntassistant®.The deposits do not affect the technical properties at the time of the examination.At the time of the examination, we do not know how the above-mentioned functional impairment occurred.Proteins in the cerebrospinal fluid can temporarily influence function and are known side effects 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 (b)(4).From our point of view, no further regulatory actions are required.

• Brand Name: SHUNTASSISTANT 20
• 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: 14114017
• Report Number: 3004721439-2022-00064
• Device Sequence Number: 19356881
• Product Code: JXG
• UDI-Device Identifier: 04041906113209
• UDI-Public: 4041906113209
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/14/2022

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 Expiration Date: 01/28/2026
• Device Model Number: FV251T
• Device Catalogue Number: FV251T
• Device Lot Number: 20051526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• 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: 16 YR
• Patient Sex: Unknown