BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2772260 · Received October 4, 2012

    Report

    Report Number
    2134265-2012-06017
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PROCEDURE TREATED THE 90% STENOSED TARGET LESION LOCATED IN A SHUNT IN A MODERATELY TORTUOUS FOREARM VESSEL. A 5.0X40MM MUSTANG BALLOON WAS ADVANCED FOR TREATMENT AND INFLATED TO 10 ATMS ON THE FIRST INFLATION, TO 15 ATMS ON THE SECOND INFLATION AND 20 ATMS ON THE THIRD INFLATION. THE BALLOON RUPTURED ON THE THIRD INFLATION AT 20 ATMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171050470 0015360541

    Patients

    Seq Age Sex Outcome Treatment
    1