BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2851722 · Received November 29, 2012

    Report

    Report Number
    2134265-2012-07167
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 2, 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

    (B)(4). DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. AN INITIAL VISUAL EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED NO TEARS IN THE BALLOON. HOWEVER, WHEN AN ATTEMPT WAS MADE TO INFLATE THE BALLOON, A PINHOLE LEAK WAS IDENTIFIED. THE PINHOLE WAS LOCATED AT 7MM PROXIMAL TO THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. A MICROSCOPIC EXAMINATION OF THE MARKERBANDS AND OF THE BALLOON MATERIAL COULD NOT IDENTIFY ANY ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE PINHOLE LEAK. 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. AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT EXTERNAL ILIAC ARTERY. THE 8.0 X 20, 75CM MUSTANG BALLOON CATHETER WAS USED FOR DILATATION OF THE LESION. UPON INFLATION AT 13ATM THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS POST PROCEDURE WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171080270 0015404191

    Patients

    Seq Age Sex Outcome Treatment
    1