BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2770610 · Received October 3, 2012

    Report

    Report Number
    2134265-2012-05909
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 6, 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. (B)(4). DEVICE EVALUATED BY MANUFACTURER: INITIAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE BALLOON MATERIAL WAS FULLY DEFLATED. AN ATTEMPT TO INFLATE THE BALLOON TO ITS RATED BURST PRESSURE FAILED DUE TO THE PRESENCE OF A PINHOLE LOCATED APPROXIMATELY 11MM DISTAL TO THE PROXIMAL TRANSITION ZONE. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT OF THE DEVICE NOTED NO ANOMALIES. 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 TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS FOREARM SHUNT. ON THE FIRST INFLATION THE MUSTANG 5.0 X 40, 75CM BALLOON WAS INFLATED TO TEN ATMOSPHERES. ON THE SECOND INFLATION THE BALLOON WAS INFLATED TO TWENTY ATMOSPHERES AND RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S 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 0015218354

    Patients

    Seq Age Sex Outcome Treatment
    1