BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3925263 · Received July 10, 2014

    Report

    Report Number
    2134265-2014-03957
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    April 7, 2014
    Report Date
    June 11, 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. 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. POSITIVE PRESSURE WAS APPLIED AND A LEAK WAS NOTED. A FURTHER MICROSCOPIC ANALYSIS NOTED A LONGITUDINAL TEAR 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 DEVICE ANALYSIS APPROVED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES WAS ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED WITH RETROGRADE APPROACH. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE FOREARM SHUNT. FOLLOWING THE INSERTION OF A 5F UNSPECIFIED INTRODUCER SHEATH AND A 35MM UNSPECIFIED GUIDE WIRE, A 5.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE AND ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON TORN LONGITUDINALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402955 MUSTANG? CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74939171050440 0016637850

    Patients

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