BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS® SD RENAL/BILIARY

    MDR report key: 3200213 · Received July 1, 2013

    Report

    Report Number
    2134265-2013-04501
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    K040027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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 DURING A RENAL STENTING TREATMENT PROCEDURE, DIFFICULTY REMOVING OR WITHDRAWING OF THE BALLOON FROM THE STENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE "VERY" SEVERELY CALCIFIED AND SEVERELY TORTUOUS RENAL ARTERY. A 6.0MMX18MMX90CM EXPRESS SD RENAL/BILIARY STENT WAS USED TO TREAT THE TARGET LESION. WHEN THE STENT WAS DEPLOYED, THE PHYSICIAN HAD "TROUBLE" REMOVING THE BALLOON FROM THE STENT. THE RESULT WAS "PERFECT" BUT IT TOOK THEM A WHILE TO GET THE BALLOON OUT BECAUSE IT WAS STUCK IN THE STENT. THEY DID NOT SNARE OR SURGICALLY REMOVE THE BALLOON. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298890 EXPRESS® SD RENAL/BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74937912618900

    Patients

    Seq Age Sex Outcome Treatment
    1