BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING MONORAIL

    MDR report key: 1111632 · Received August 13, 2008

    Report

    Report Number
    2134265-2008-02308
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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

    AS NO DEVICE WAS REC'D FOR ANALYSIS, IT IS NOT POSSIBLE TO PERFORM ANY INSPECTIONS ON THE DEVICE. THE MANUFACTURING RECORDS FOR THIS BATCH HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED OPERATIONAL CONTEXT DUE TO THE LIKELIHOOD THAT THE PT ANATOMY OR OTHER PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED DIFFICULTY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A STERLING 4.0 X 60/135 BALLOON WAS INFLATED TO 7 ATMOSPHERES AND RUPTURED. THE BALLOON WAS REMOVED INTACT. PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PT STATUS IS LISTED AS GOOD WITH NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING MONORAIL DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION NA 11725806

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR STENT: SMART| INFLATION DEVICE: EVEREST| INTRODUCER SHEATH: ANSELL 6F| GW: TREASURE