BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 2013318 · Received March 10, 2011

    Report

    Report Number
    3005099803-2011-00595
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE GUIDE CATHETER WAS BROKEN INTO TWO PIECES. THE PROXIMAL PORTION WAS STRETCHED AND ACCORDIONED, AND THE DISTAL END WAS STRETCHED AND COLLAPSED. THE SUTURE WAS MISSING, AND THE SUTURE HOLE WAS TORN TOWARDS THE DISTAL END OF THE PUSH CATHETER. THE STENT WAS NOT RETURNED. A FUNCTIONAL EXAMINATION COULD NOT BE PERFORMED, DUE TO THE DAMAGES ON THE RETURNED DEVICE.BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION CONDUCTED, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUES IS OPERATIONAL CONTEXT.A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT SYSTEM WAS IMPLANTED WITHIN THE COMMON BILE DUCT OF A PATIENT DURING AN ENDOSCOPIC BILIARY DRAINAGE PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE GUIDE CATHETER STRETCHED; HOWEVER THE STENT WAS ABLE TO BE SUCCESSFULLY IMPLANTED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE GOOD. THE INVESTIGATION RESULTS REVEALED THAT THE GUIDE CATHETER WAS BROKEN. THEREFORE, THIS EVENT IS NOW CONSIDERED REPORTABLE.

    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 M00539260 13468604

    Patients

    Seq Age Sex Outcome Treatment
    1