MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 15; HYDROCEPHALUS MANAGEMENT

Model Number	FV250T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: optical inspection: first step of our investigation is the optical inspection.The visual inspection revealed that the shuntassistant has no deformations or other abnormalities.Permeability test: to proof the penetrability of the valve we carried out a penetrability test.This test was carried out at a hydrostatic pressure of approx.30 cmh2o in the flow direction.The test results that the shuntassistant was not penetrable.Adjustment test: an adjustment test is not applicable, because the valve has a fixed pressure level.Braking force and brake function test: a braking force and brake function test is not applicable, because the valve has a fixed pressure level.Result: first we performed a visual inspection with the shuntassistant.The investigation revealed that the valve has no deformations or other abnormalities.In the further course of the investigation, we tested the permeability of the shuntassistant.The test results that the valve was not penetrable.To clarify whether any deposits inside the valve could have affect the valves's permeability, we decided to dismantle the valve.Inside the valve we have found obvious deposits of protein, which might have led to the suspected blockage as well as the assumed underdrainage.Based on our investigation results there is no failure detectable with this valve.Rather, the suspected underdrainage or blockage is a described side effect in the treatment with shunts.
Event or Problem Description
It was reported that a shuntassistant 15 (# fv250t) was implanted during a procedure performed on unknown date.According to the complainant, the shunt system was believed to be operated in underdrainage.The patient underwent a revision procedure on (b)(6) 2017.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.

• Brand Name: SHUNTASSISTANT 15
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12730317
• Report Number: 3004721439-2021-00711
• Device Sequence Number: 4499008
• Product Code: JXG
• UDI-Device Identifier: 04041906113100
• UDI-Public: 4041906113100
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

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: 12/31/2020
• Device Model Number: FV250T
• Device Catalogue Number: FV250T
• Device Lot Number: 20031282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2017
• Initial Report FDA Received Date: 11/01/2021
• 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