MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG DUALSWITCH-VALVE 10/30; HYDROCEPHALUS MANAGEMENT

Model Number	FV100T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: no significant deformations or other abnormalities of the valve were detected during the visual inspection.Permeability test: a permeability test has shown that the valve is permeable.Computer controlled test: to investigate the claim of a blockage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in both the horizontal as well as the vertical positions.The results show that the valve operates within the accepted tolerance in both positions.Internal inspection: after dismantling of the valve, deposits were found in dsv.Results: we would like to note in advance that the returned product was not submerged in liquid at the time of receipt.The testing of valves sent in a dry condition is only of a limited value.The product performance can be affected by dry residues of cerebrospinal fluid or blood.Despite this we have tested the device to the best of our abilities based on our examination results, we can detect deposits.The deposits do not affect the technical characteristics at the time of the examination.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.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a dualswitch-valve 10/30 (dsv) (part # fv100t) was implanted during a procedure performed on (b)(6) 2020.According to the complainant, the shunt system was believed to be clogged.The patient underwent a revision procedure on (b)(6) 2022.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6), height: (b)(6), weight: (b)(6), gender: unknown.

• Brand Name: DUALSWITCH-VALVE 10/30
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): UNIVERSITAETSKLINIKUM HEIDELBERG; im neuenheimer feld 672; heidelberg, 69120 ; GM 69120
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 14017476
• Report Number: 3004721439-2022-00073
• Device Sequence Number: 6288053
• Product Code: JXG
• UDI-Device Identifier: 04041906101008
• UDI-Public: 4041906101008
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2022

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: 03/01/2025
• Device Model Number: FV100T
• Device Catalogue Number: FV100T
• Device Lot Number: 20046386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2020
• 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: 18 YR
• Patient Sex: Unknown
• Patient Weight: 78 KG