BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING MONORAIL

    MDR report key: 1172133 · Received September 18, 2008

    Report

    Report Number
    2134265-2008-02716
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2008-02718 & 2134265-2008-02717. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOTIC LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATE TO SEVERELY CALCIFIED POSTERIOR TIBIAL ARTERY. THE PHYSICIAN ADVANCED A 3.0X40MM STERLING BALLOON CATHETER TO THE LESION AND ON THE SECOND INFLATION, INFLATED THE BALLOON TO 10ATMS AND THE BALLOON RUPTURED. THE PHYSICIAN THEN ADVANCED A 3.0X20 STERLING BALLOON CATHETER TO THE LESION AND ON THE SECOND INFLATION, INFLATED IT TO 6ATMS AND THE BALLOON RUPTURED. THEN THE PHYSICIAN ADVANCED ANOTHER 3.0X20 STERLING BALLOON CATHETER TO THE LESION AND ON THE SECOND INFLATION, INFLATED IT TO 6ATMS AND THE BALLOON RUPTURED. THERE WERE NO PATIENT COMPLICATIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SYMMETRY BALLOON CATHETER. PATIENT STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING MONORAIL DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC NA 11745661

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR