BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 3090579 · Received May 2, 2013

    Report

    Report Number
    2134265-2013-02977
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED 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 DURING A BALLOON ANGIOPLASTY OF THE LEFT SUPERFICIAL FEMORAL ARTERY, A BALLOON RUPTURE OCCURRED. THE CALCIFIED TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A 4.0 X 20, 135CM MUSTANG BALLOON CATHETER WAS USED FOR INFLATION BUT IT RUPTURED UNDER AN UNKNOWN RATED BURST PRESSURE. THEY PULLED IT OUT ENTIRELY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192860 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171040210 15552607

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR