MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG SPRUNG RESERVOIR SET W/DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number FV046T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/27/2020

Event Type  Injury  

Manufacturer Narrative

If additional information becomes available a follow up report will be submitted.

Event Description

It was reported that there is an issue with valve.The reporter indicated that a post-operative valve does not flow properly, so, the surgeon did the revision surgery and implanted other company valve.The ventrical catheter and reservoir from miethke have been used together with the other company valve.Thus, the surgeon would like to know whether there was blockage of the valve.The device was explanted.Additional event details and patient information have not provided, however, have been requested.

Manufacturer Narrative

Investigation visual inspection during the visual investigation, it is verified whether the returned product has any defects, deformations or other deviations.Permeability test to check if the burr hole reservoir is blocked, we have performed a permeability test.This test is performed at a hydrostatic pressure of approximately 30 cmh2o in the horizontal direction of flow.Results in the first investigation, we detected no significant deformations or damage of the reservoir.The investigation of permeability revealed that the reservoir could filled with liquid and drained the fluid easily.The ventricular catheter is permeable, too.Based on our investigations we cannot confirm a blockage of the reservoir at the time of the investigation.The malfunction complained of cannot be explained to us at the time.We exclude a defect at the time of release.At the time of release by christoph miethke gmbh & co kg our products meet all specifications of the final inspection.Further actions no further regulatory actions are required from our point of view.

• Brand Name: SPRUNG RESERVOIR SET W/DISTAL CATHETER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9853765
• MDR Text Key: 188550866
• Report Number: 3004721439-2020-00067
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K110206
• 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: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FV046T
• Device Catalogue Number: FV046T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention