BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2840463 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07021
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 29, 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

    DEVICE EVALUATED BY MFR: AN EXAMINATION OF THE RETURNED DEVICE FOUND THAT A LONGITUDINAL TEAR EXISTED IN THE BALLOON MATERIAL. THE TEAR STRETCHED FROM 5MM PROXIMAL TO THE PROXIMAL MARKERBAND AND IT EXTENDED PAST THE DISTAL MARKERBAND, MEASURING 50MM IN LENGTH. AN EXAMINATION OF BOTH THE PROXIMAL AND DISTAL MARKERBANDS IDENTIFIED NO ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE TEAR. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE UNCALCIFIED AND MODERATELY TORTUOUS SHUNT. THE PHYSICIAN INFLATED A 6.0 X 40, 75CM MUSTANG BALLOON CATHETER IN THE TARGET LESION A 24 ATMS. UPON THE SECOND INFLATION THE BALLOON RUPTURED AT 24 ATMS. THE DEVICE WAS SUCCESSFULLY REMOVED. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE UNCALCIFIED AND MODERATELY TORTUOUS SHUNT. THE PHYSICIAN INFLATED A 6.0 X 40, 75CM MUSTANG BALLOON CATHETER IN THE TARGET LESION A 24ATMS. UPON THE SECOND INFLATION THE BALLOON RUPTURED AT 24ATMS. THE DEVICE WAS SUCCESSFULLY REMOVED. NO 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 H74939171060470 15509031

    Patients

    Seq Age Sex Outcome Treatment
    1