MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG DSV SYSTEM W/PRECHAMBER 10/40; HYDROCEPHALUS MANAGEMENT

Model Number	FV173T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/09/2021
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 indicated that the valve has a blockage.Computer controlled test: to investigate the claim of over/under-drainage, 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.Because the valve is not permeable, a computer controlled test is not possible.Adjustability test: the test is not applicable, because the dsv is a fixed pressure valve.Results: first, we performed a visual inspection of the dsv.No significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability of the valve.The valve was shown to have a blockage.Then we carried out a computer controlled simulated flow test.Due to the nonpermeability of the valve, a computer controlled test was not possible to further investigate the claim of under-drainage.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we confirm the presence of under drainage/occlusion in the valve, likely due to the deposits observed inside the valve.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.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 dsv system w/prechamber 10/40dsv (part # fv173t) was implanted during a procedure performed on (b)(6) 2020.According to the complainant, the valve was believed to be operating in overdrainage and had a problem with adjustability.The patient underwent a revision procedure on (b)(6) 2021.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) years, height: 193 centimeters (cm), weight: (b)(6) kilograms (kg), gender: male.

• Brand Name: DSV SYSTEM W/PRECHAMBER 10/40
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12306441
• Report Number: 3004721439-2021-00216
• Device Sequence Number: 11737637
• Product Code: JXG
• UDI-Device Identifier: 04041906108304
• UDI-Public: 4041906108304
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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: 05/27/2024
• Device Model Number: FV173T
• Device Catalogue Number: FV173T
• Device Lot Number: 20042770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Weight: 120