BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 3098905 · Received May 8, 2013

    Report

    Report Number
    2134265-2013-02957
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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 DURING A PREDILATATION OF THE SUPERIOR MESENTERIC ARTERY, A BALLOON BURST OCCURRED. ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND NON TORTUOUS SUPERIOR MESENTERIC ARTERY. A 5.0 X 20, 135CM MUSTANG BALLOON DILATATION CATHETER WAS USED TO PREDILATE THE TARGET LESION. UPON THE FIRST INFLATION, THE BALLOON BURST AT 11 ATMOSPHERES. THE BALLOON WAS RETRIEVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201207 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171050210

    Patients

    Seq Age Sex Outcome Treatment
    1