BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUALIZER BALLOON CATHETER

    MDR report key: 1242899 · Received November 19, 2008

    Report

    Report Number
    2134265-2008-04377
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K021721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR AN INTERVENTIONAL PROCEDURE, BALLOON CATHETER BREAKAGE OCCURRED. THE EQUALIZER 7 X 2MM AND 65 CM BALLOON CATHETER WAS REPORTED BROKEN DURING PREPARATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNSPECIFIED DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S CURRENT STATUS IS REPORTED AS "FINE." ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUALIZER BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC 17-107 0011931110

    Patients

    Seq Age Sex Outcome Treatment
    1