MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG SHUNTASST 25 W/ATT DISTAL & PROX TUBING; HYDROCEPHALUS MANAGEMENT

Model Number FV257T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

Height: 183 cm.When additional information becomes available a follow up report will be submitted.

Event Description

It was reported the valve was blocked.The reporter indicated that a 5 year 27 day post operative valve was blocked and required explantation.Additional information was not provided.

Manufacturer Narrative

Investigation: visual inspection: no significant deformations or damage of the valves were detected during the visual inspection.Permeability test: a permeability test has shown that the valve is permeable.Adjustment test: for the shunt assistant the adjustment test is not applicable, because it is a valve with a fixed pressure.Braking force and brake function test: for the shunt assistant the test is not applicable, because it is a valve with a fixed pressure.Results: first, we performed a visual inspection of the valve.No significant deformations or damages of the valve are detected during the visual inspection.Further, we tested the permeability of the valve.The test has shown, that the valve is permeable.In order to verify whether the valve is 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 fluid1, we have dismantled the valve.There were no visible deposits observed inside the shunt assistant.Based on our investigation results, we cannot confirm the suspicion of a blockage.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.Further actions: no further actions are required in our point of view.

• Brand Name: SHUNTASST 25 W/ATT DISTAL & PROX TUBING
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9591886
• MDR Text Key: 175093073
• Report Number: 3004721439-2020-00018
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K011030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2017
• Device Model Number: FV257T
• Device Catalogue Number: FV257T
• Device Lot Number: 20018869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 MO
• Patient Weight: 80