BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3951112 · Received July 22, 2014

    Report

    Report Number
    2134265-2014-04240
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 26, 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 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 BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED UNSPECIFIED VESSEL OF THE FOREARM. THE 4.0 X 40, 40CM MUSTANG¿ BALLOON CATHETER WAS SELECTED. THE LESION WAS DILATED SEVERAL TIMES; HOWEVER IT WAS NOT DILATED ENOUGH. WHEN THE INFLATION PRESSURE WENT UP TO 20 ATMS, IT WAS NOTED THAT THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427673 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171040440 16753597

    Patients

    Seq Age Sex Outcome Treatment
    1