BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING MONORAIL

    MDR report key: 1063784 · Received June 18, 2008

    Report

    Report Number
    2134265-2008-01718
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE TWO BALLOON RUPTURES OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS DILATED WITH A 4.0X30MM STERLING MONORAIL BALLOON AND THE BALLOON RUPTURED ON THE FIRST INFLATION AT 10ATMS AFTER 5 SECONDS. THE BALLOON WAS CHANGED TO A 5.0X40MM STERLING MONORAIL BALLOON. THE 5.0X40MM BALLOON WAS INFLATED FOR THE FIRST TIME AND RUPTURED AT 8ATMS AFTER 30 SECONDS. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. NO PT COMPLICATIONS WERE REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING MONORAIL DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC NA 11223357

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR SYNERGY 5.0X40MM BALLOON