BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAILOR PLUS

    MDR report key: 770250 · Received October 3, 2006

    Report

    Report Number
    770250
    Event Type
    Malfunction
    Date Received
    October 3, 2006
    Date of Event
    September 29, 2006
    Report Date
    October 3, 2006
    Manufacturer
    EV3 INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SAILOR PLUS BALLOON INFLATED TO 12 ATM RUPTURED WHILE INSIDE THE PATIENT. IMMEDIATELY AFTER THE RUPTURE, THE PHYSICIAN ATTEMPTED TO PULL THE BALLOON OUT, BUT THE BALLOON TIP BROKE OFF IN THE (6F) SHEATH. THE MALFUNCTION RESULTED IN DEACCESS OF THE FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAILOR PLUS CATHETER, BALLOON DQY EV3 INC. * 01962701

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR