BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK ELITE RE-ENTRY CATHETER

    MDR report key: 14376564 · Received May 11, 2022

    Report

    Report Number
    MW5109660
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    April 22, 2022
    Report Date
    May 10, 2022
    Manufacturer
    CORDIS US CORP.
    Product Code
    PDU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A CORDIS OUTBACK DEVICE WAS INSERTED THROUGH A 6FR 45 CM DESTINATION SHEATH OVER A V18 WIRE. BEFORE THE DEVICE CAME OUT OF THE SHEATH THE TIP F THE DEVICE BROKE OFF. THE TIP WAS STILL ATTACHED TO THE WIRE. THE DOCTOR PULLED THE SHEATH OUT AND RETRIEVED THE DEVICE FROM THE SHEATH WITHOUT ANY INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2504720 OUTBACK ELITE RE-ENTRY CATHETER CATHETER FOR CROSSING TOTAL OCCLUSIONS PDU CORDIS US CORP. 1807347

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female