BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM

    MDR report key: 1884307 · Received October 27, 2010

    Report

    Report Number
    3005099803-2010-04504
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):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 STENT WAS RETURNED WITH A PIGTAIL STRAIGHTENER (ORANGE SLEEVE). THERE WAS A KINK AT THE SIDEPORT HOLE NEAR THE TAPERED END OF THE STENT. THERE WERE NO OTHER DAMAGES ON THE STENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX DOUBLE PIGTAIL BILIARY STENT WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE BILIARY DUCT OF A FEMALE PATIENT (PATIENT AGE AND WEIGHT ARE UNKNOWN). DURING THE PREPARATION, AS THE DOUBLE PIGTAIL STENT WAS LOADED ON THE GUIDEWIRE, THE STENT KINKED AND THE GUIDEWIRE COULD NOT BE ADVANCED THROUGH THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER AN ADVANIX DOUBLE PIGTAIL BILIARY STENT AND NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX DOUBLE PIGTAIL BILIARY STENT WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE BILIARY DUCT OF A FEMALE PATIENT (PATIENT AGE AND WEIGHT ARE UNKNOWN). DURING THE PREPARATION, AS THE DOUBLE PIGTAIL STENT WAS LOADED ON THE GUIDEWIRE, THE STENT KINKED AND THE GUIDEWIRE COULD NOT BE ADVANCED THROUGH THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER AN ADVANIX DOUBLE PIGTAIL BILIARY STENT AND NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN GOOD 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 M00532190 13485119

    Patients

    Seq Age Sex Outcome Treatment
    1