BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS BILIARY SD

    MDR report key: 1841541 · Received September 22, 2010

    Report

    Report Number
    2134265-2010-04166
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    K040027
    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 (B)(4). DEVICE EVALUATED BY MANUFACTURER: 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 A RENAL ARTERY TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. AN UNSPECIFIED EXPRESS BILIARY STENT DELIVERY SYSTEM WAS ADVANCED AND DEPLOYED IN THE RIGHT RENAL ARTERY. IT APPEARED AFTER THE STENT DELIVERY BALLOON WAS INFLATED A COUPLE OF TIMES AT APPROXIMATELY 10 ATMS, THE STENT FLARED AND APPEARED TO HAVE A CRACK. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THE STENT WAS REPORTED TO BE FULLY APPOSED TO THE ARTERY WALL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS BILIARY SD CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE UNK500

    Patients

    Seq Age Sex Outcome Treatment
    1