BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2834192 · Received November 15, 2012

    Report

    Report Number
    2134265-2012-06927
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    September 6, 2012
    Report Date
    October 23, 2012
    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

    AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT WAS INDICATED THAT THE DEVICE WOULD NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE LEFT A/V GRAFT VEIN. THE PHYSICIAN ADVANCED A 6.0 X 40, 40 CM MUSTANG BALLOON CATHETER TO THE TARGET LESION. UPON INFLATION THE BALLOON RUPTURE AND TORE CIRCUMFERENTIAL RATHER THAN LENGTHWISE. THE DEVICE AND SHEATH WERE REMOVED AS A UNIT. THE PROCEDURE WAS COMPLETED BY IMPLANTING AN UNKNOWN STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S WAS ALERT AND ORIENTATED POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171060440

    Patients

    Seq Age Sex Outcome Treatment
    1