BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS® LD BILIARY

    MDR report key: 3971658 · Received July 31, 2014

    Report

    Report Number
    2134265-2014-04529
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K032360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR.:IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION STENT DISLODGEMENT OCCURRED. A 5.0X20X135CM EXPRESS® LD BILIARY STENT WAS SELECTED HOWEVER, WHEN THE PHYSICIAN OPENED THE PACKAGE, THE STENT SLID COMPLETELY OFF OF THE BALLOON AND LANDED ON THE TABLE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447762 EXPRESS® LD BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938047520130 15756917

    Patients

    Seq Age Sex Outcome Treatment
    1