BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS SD BILIARY STENT SYSTEM

    MDR report key: 1840477 · Received September 21, 2010

    Report

    Report Number
    2134265-2010-04250
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 31, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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 STENTING TREATMENT PROCEDURE, BALLOON WITHDRAWAL DIFFICULTIES OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT RENAL ARTERY. THIS 6.0X14X90CM EXPRESS BILIARY SD STENT WAS ADVANCED TO THE LESION AND DEPLOYED. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE STENT DELIVERY SYSTEM (SDS), HOWEVER, THE TIP OF THE BALLOON CAUGHT ON THE DEPLOYED STENT. THERE WERE NO ISSUES WITH THE BALLOON DEFLATING, THE BALLOON WAS FULLY DEFLATED. THE PHYSICIAN STOPPED PULLING ON THE DEVICE, REMOVED ALL THE CONTRAST, AND INJECTED 1 TO 2 CC'S OF 100% SALINE. THE BALLOON WAS DEFLATED AGAIN AND A GUIDE CATHETER WAS ADVANCED UP TO THE BALLOON. THE SDS WAS THEN PULLED BACK INTO THE GUIDE CATHETER AND THE DEVICES WERE REMOVED SUCCESSFULLY. THE PROCEDURE WAS CONSIDERED COMPLETE WITH THIS DEVICE. 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 SD BILIARY STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74937911614900 13126355

    Patients

    Seq Age Sex Outcome Treatment
    1