BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX INTRACRANIAL CATHETER

    MDR report key: 3070841 · Received April 22, 2013

    Report

    Report Number
    2029214-2013-00389
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    April 1, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED FOR EVALUATION AND IT WAS FOUND TO BE DAMAGED AT 22.5CM FROM THE DISTAL TIP AND BROKEN (BUT RETAINED BY THE INNER LAYER) AT 18CM FROM THE DISTAL TIP. THE DAMAGE LIKELY OCCURRED DURING NAVIGATION THROUGH THE EXCESSIVE BENDING AND TWISTING TORTUOUS ANATOMY SINCE THE CATHETER SHOULD HAVE BEEN INSPECTED FOR DAMAGES PRIOR TO USE AS STATED IN THE IFU (INSTRUCTIONS FOR USE). (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. DURING THE PROCEDURE IN A TORTUOUS ANATOMY, IT WAS REPORTED THAT THE DISTAL PART OF THE CATHETER KINKED AROUND THE AORTIC ARC. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171452 REFLEX INTRACRANIAL CATHETER GUIDE CATHETER DQY EV3 NEUROVASCULAR RFXA072-105-08MP 12542

    Patients

    Seq Age Sex Outcome Treatment
    1