BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM

    MDR report key: 2133948 · Received June 20, 2011

    Report

    Report Number
    3005099803-2011-02139
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE STENT WAS LOADED ON THE GUIDE CATHETER BUT THE SUTURE WAS NOT RETURNED FOR EVALUATION. THE STENT REVEALED SCRATCHES ON ITS WORKING LENGTH AND THE DISTAL BARB APPEARED JAGGED. THE STENT SUTURE HOLE WAS TORN. THE PULLWIRE, INSIDE THE PUSH CATHETER, APPEARED SLIGHTLY BENT AT MULTIPLE LOCATIONS CAUSING THE PUSH CATHETER TO APPEAR BENT AT MULTIPLE LOCATIONS. A FUNCTIONAL EVALUATION REVEALED THERE WAS RESISTANCE DURING THE ACTUATION (RETRACTION AND EXTENSION) OF THE HANDLE ASSEMBLY. THERE WAS NO VISIBLE DAMAGE TO THE GUIDE CATHETER. BASED ON THE CONDITION OF THE DEVICE AND THE DETAILS OF THE EVENT, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. 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 ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN AN (B)(6) MALE PATIENT WEIGHING (B)(6). DURING THE PROCEDURE, RESISTANCE WAS MET ADVANCING THE ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM INTO THE DUCT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN OKAY CONDITION AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN AN (B)(6) OLD MALE PATIENT WEIGHING (B)(6). DURING THE PROCEDURE, RESISTANCE WAS MET ADVANCING THE ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM INTO THE DUCT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN OKAY CONDITION AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM BILIARY CATHETERS AND ACCESSORIES FGE BOSTON SCIENTIFIC - SPENCER M00534330 13546380

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR