BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIEN INTRACRANIAL CATHETER

    MDR report key: 3140590 · Received May 31, 2013

    Report

    Report Number
    2029214-2013-00501
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED FOR EVALUATION AND IT WAS FOUND TO BE SEPARATED AT 20.7CM FROM THE CATHETER TIP LIKELY DUE TO THE TORTUOUS ANATOMY AND FROM APPLYING TOO MUCH FORCE TO THE CATHETER BODY; HOWEVER, THE BROKEN SEGMENTS WERE RETAINED BY THE INNER LAYER. THE DEVICE HAS TO BE INSPECTED FOR ANY DAMAGE PRIOR TO USE PER THE IFU (INSTRUCTIONS FOR USE).(B)(4).

    Description of Event or Problem · 1

    ANGIOPLASTY FOR VASOSPASM. DURING THE PROCEDURE IN A TORTUOUS ANATOMY, IT WAS REPORTED THAT THE NAVIEN CATHETER WITH A HYPERFORM BALLOON INSIDE BECAME KINKED AT THE DISTAL TIP AND A PIECE OF THE CATHETER CAME LOOSE FROM THE SHAFT WHICH WAS EVENTUALLY RETRIEVED FROM THE PATIENT.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240919 NAVIEN INTRACRANIAL CATHETER GUIDE CATHETER DQY EV3 NEUROVASCULAR RFX058-115-08 9681102

    Patients

    Seq Age Sex Outcome Treatment
    1