BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3892526 · Received June 24, 2014

    Report

    Report Number
    2134265-2014-03493
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    April 2, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K110122
    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 MFR.: A VISUAL AND TACTILE EXAMINATION OF THE RETURNED DEVICE FOUND NO KINKS OR DAMAGE ALONG THE ENTIRE LENGTH OF THE DEVICE. THE TIP PROFILE OF THE DEVICE SHOWED NO DEFECTS. POSITIVE PRESSURE WAS APPLIED AND A LEAK WAS NOTED. A FURTHER MICROSCOPIC ANALYSIS REVEALED A LONGITUDINAL TEAR MEASURING 41MM IN LENGTH IN THE BALLOON BODY. AN EXAMINATION OF THE BALLOON MATERIAL AND MARKERBANDS IDENTIFIED NO ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE TEAR. NO OTHER DEFECTS WERE NOTED. 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

    REPORTABLE BASED ON PRELIMINARY DEVICE ANALYSIS RECEIVED ON (B)(4) 2014. IT WAS REPORTED THAT CATHETER CROSSING DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED UTILIZING A RETROGRADE APPROACH. THE TARGET LESION WAS LOCATED IN A SHUNT OF THE FOREARM. THE 5.0 X 40, 40CM MUSTANG¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION AND THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER SIZE OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD. HOWEVER, PRELIMINARY DEVICE ANALYSIS REVEALED A BALLOON TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368254 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171050440 0016703441

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: 35WIRE| INTRODUCER SHEATH: 5F SHEATH