BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX WALLSTENT BILIARY ENDOPROSTHESIS

    MDR report key: 1081442 · Received July 25, 2008

    Report

    Report Number
    3005099803-2008-01304
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WOULD 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, A SHAFT FRACTURE OCCURRED. THE TARGET LESION WAS IN THE COMMON BILE DUCT AND COMMON HEPTATIC DUCT. A 10X60MM WALLSTENT RX BILIARY STENT HAD BEEN DEPLOYED IN THE TARGET LESION. DURING WITHDRAWAL, THE "INTERNAL STYLET" BECAME "SNAGGED ON SOMETHING WITHIN THE BILIARY SYSTEM". THE PHYSICIAN PULLED "HARDER" ON THE DELIVERY CATHETER. THE "INTERNAL STYLET" DETACHED FROM THE DELIVERY CATHETER AND WAS "LEFT IN THE DUCT". THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO ADDITIONAL PT COMPLICATIONS REPORTED WITH THE PT'S CONDITION LISTED AS "FINE". THE PHYSICIAN WAS REPORTEDLY PLANNING ON MAKING AN RETRIEVAL ATTEMPT " IN A COUPLE OF DAYS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX WALLSTENT BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC M00569650 11573256

    Patients

    Seq Age Sex Outcome Treatment
    1 Other