BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 2023240 · Received March 18, 2011

    Report

    Report Number
    3005099803-2011-00770
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED; HOWEVER THE EVALUATION HAS NOT YET BEEN COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE GUIDE CATHETER WAS BROKEN/SEPARATED FROM THE PULLWIRE. THE BROKEN GUIDE CATHETER WAS FREE OF KINKS/BENDS. THE PROXIMAL END OF THE GUIDE CATHETER WAS TORN. THERE WERE NO DAMAGES ON THE PUSH CATHETER AND THE WELDED PULLWIRE/CANNULA. THE STENT WAS NOT RETURNED FOR EVALUATION. BASED ON THE CONDITION OF THE DEVICE AND THE DETAILS OF THE EVENT, THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE EVENT DESCRIPTION AND PRODUCT ANALYSIS DO NOT PROVIDE SUFFICIENT INFORMATION TO CONCLUDE A PROBABLE ROOT CAUSE FOR THE COMPLAINT. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RAPID EXCHANGE BILIARY STENT SYSTEM WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6), 2011. DURING PREPARATION, AS THE DEVICE WAS LOADED ONTO THE GUIDEWIRE, THE GUIDE CATHETER DETACHED FROM THE SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER RAPID EXCHANGE BILIARY STENT SYSTEM WITH NO REPORTED PATIENT COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RAPID EXCHANGE BILIARY STENT SYSTEM WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6), 2011. DURING PREPARATION, AS THE DEVICE WAS LOADED ONTO THE GUIDEWIRE, THE GUIDE CATHETER DETACHED FROM THE SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER RAPID EXCHANGE BILIARY STENT SYSTEM WITH NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00545600 13481942

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR