BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM

    MDR report key: 2123967 · Received June 14, 2011

    Report

    Report Number
    3005099803-2011-02030
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN, BUT IS REPORTEDLY (B)(6). (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 EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE SUTURE WAS DETACHED/SEPARATED FROM THE PUSH CATHETER AND NOT RETURNED FOR EVALUATION. THE PUSH CATHETER WAS RIPPED/TORN APPROXIMATELY 11CM FROM THE PROXIMAL HUB OF DELIVERY SYSTEM WITH THE PULL WIRE ASSEMBLY SEVERELY BENT AND EXPOSED AT THIS LOCATION. THE PROXIMAL END OF THE PULL WIRE NEAR THE HANDLE WAS KINKED. THE GUIDE CATHETER REMAINED INSIDE THE DELIVERY SYSTEM AND COULD NOT BE RETRIEVED AS THE PULL WIRE ASSEMBLY COULD NOT BE ACTUATED (EXTENDED OR RETRACTED) DUE TO THE DAMAGES OBSERVED. DURING THE INVESTIGATION, THE PUSH CATHETER WAS CUT AT MULTIPLE LOCATIONS TO EVALUATE THE GUIDE CATHETER. INITIALLY, NO DAMAGE WAS OBSERVED TO THE GUIDE CATHETER, BUT THE GUIDE CATHETER WAS INADVERTENTLY CUT DURING INVESTIGATION. THE STOP CANNULA ON THE PULL WIRE WAS PUSHED INSIDE THE DUAL LUMEN CATHETER LIKELY DUE TO THE EXCESSIVE PULL FORCE EXERTED DURING USE. THE STENT WAS NOT RETURNED FOR EVALUATION. BASED ON THE CONDITION OF THE DEVICE AND THE DETAILS OF THE EVENT, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT 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 AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED DURING A STENTING PROCEDURE IN THE COMMON BILE DUCT OF A PATIENT (PATIENT AGE, SEX, AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, AS THE PULLWIRE WAS RETRACTED FOR SUCCESSFUL STENT DEPLOYMENT, THE PULLWIRE TORE THROUGH THE PUSH CATHETER NEAR THE HUB. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED PATIENT COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX' BILIARY STENT WITH NAVIFLEX' RX DELIVERY SYSTEM WAS USED DURING A STENTING PROCEDURE IN THE COMMON BILE DUCT OF A PATIENT (PATIENT AGE, SEX, AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, AS THE PULLWIRE WAS RETRACTED FOR SUCCESSFUL STENT DEPLOYMENT, THE PULLWIRE TORE THROUGH THE PUSH CATHETER NEAR THE HUB. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED PATIENT COMPLICATIONS.

    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 M00534210 13626404

    Patients

    Seq Age Sex Outcome Treatment
    1