BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3822517 · Received May 21, 2014

    Report

    Report Number
    2134265-2014-02706
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K110122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). AFTER A NON-BSC STENT WAS DEPLOYED, POST DILATATION WAS PERFORMED USING A 6.0 X 150, 75CM MUSTANG¿ CATHETER BALLOON. DURING THE FIRST INFLATION IT RUPTURED AT 16 ATMOSPHERES (ATMS) WITH A DURATION OF 10 SECONDS. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A 6MMX100MM MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303768 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171061570 0015253777

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: RADIFOCUS| STENT: SMART 8MMX150, 100MM| INTRODUCER SHEATH: TERUMO 6FR-10CM