BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO BALLOON CATHETER

    MDR report key: 3980466 · Received June 5, 2014

    Report

    Report Number
    9612007-2014-00016
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 12, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS SA
    Product Code
    GWG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE REPORTED INCIDENT ARE NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS REGARDING THE NEURO BALLOON CATHETER (SAME REPORTER, SAME PRODUCT PROBLEM, DIFFERENT INCIDENTS, DIFFERENT SURGEONS). IT WAS REPORTED THAT WHEN PERFORMING A THIRD VENTRICULOSTOMY, THE TIP BENT AND THE NEURO BALLOON CATHETER WAS DISCARDED. A SECOND NEURO BALLOON CATHETER WAS OPENED AND IT BENT AGAIN. THE PROCEDURE WAS STILL COMPLETED SUCCESSFULLY USING THE SECOND NEUROBALLOON CATHETER. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY OR DEATH ALLEGED. THE EVENT LED TO A 15 MINUTE INCREASE IN SURGERY TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT TO DATE, NO NEW INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329903 NEURO BALLOON CATHETER NEUROENDOSCOPY GWG INTEGRA NEUROSCIENCES IMPLANTS SA

    Patients

    Seq Age Sex Outcome Treatment
    1