BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS® SD RENAL/BILIARY

    MDR report key: 3781073 · Received April 30, 2014

    Report

    Report Number
    2134265-2014-02249
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    K040027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. 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 STENT MOVEMENT ON BALLOON OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED AND HEAVILY TORTUOUS MESENTERIC ARTERY. A 6F UNSPECIFIED GUIDE CATHETER WAS USED. THEN THE 5.0MMX19MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED TO THE LESION HOWEVER THE STENT STARTED MOVING ON THE DELIVERY SYSTEM BALLOON. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A 5MM X 15MM EXPRESS SD RENAL/BILIARY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260576 EXPRESS® SD RENAL/BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74937912519150 16055979

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR