BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM

    MDR report key: 2260089 · Received September 22, 2011

    Report

    Report Number
    3005099803-2011-03187
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    June 28, 2011
    Report Date
    August 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN. THE DELIVERY SYSTEM AND THE STENT WERE RETURNED FOR EVALUATION. THE GUIDEWIRE WAS ALSO RETURNED LOADED IN THE DELIVERY SYSTEM, EXITING THE RAMP WINDOW; IT COULD NOT BE REMOVED DUE TO BEING STUCK AT THIS LOCATION. VISUAL EVALUATION OF THE COMPLAINT DEVICE WAS PERFORMED. TH PULL WIRE ASSEMBLY WAS FOUND TO BE COILED AND KINKED AT THE PROXIMAL END OF THE DELIVERY SYSTEM. THE STENT WAS FOUND DETACHED FROM THE DELIVERY SYSTEM. THE STENT PROXIMAL TIP AND SUTURE HOLE WERE FOUND TO BE TORN. THE SUTURE WAS FOUND DETACHED AND WAS NOT RETURNED FOR EVALUATION. THE PUSH CATHETER WAS FOUND KINKED AT THE DISTAL RADIO OPAQUE MARKER LOCATION. THE SUTURE HOLE ON THE PUSH CATHETER WAS FOUND TORN. THE PUSH CATHETER WAS FOUND TORN AND SPLIT AT THE PROXIMAL END NEAR THE LOCKING DEVICE. THE PULL WIRE WAS EXPOSED AT THIS LOCATION. THE PUSH CATHETER WAS CUT NEAR THE DISTAL END TO OBSERVE THE GUIDE CATHETER ASSEMBLY. THE WORKING LENGTH OF GUIDE CATHETER WAS FOUND INTACT. THE GUIDE CATHETER ASSEMBLY WAS FOUND TO CONTAIN STICKY TRANSPARENT RESIDUE THROUGHOUT THE DISTAL END OF GUIDE CATHETER. A RESIDUE SAMPLE WAS TESTED AND IT WAS DETERMINED THAT THE RESIDUE IS NEITHER GLUE NOR MEDIGLIDE, THE SUBSTANCES APPLIED TO THE DEVICE DURING MANUFACTURING. AS THE RESIDUE COULD NOT BE IDENTIFIED, IT REMAINS UNKNOWN IF IT WAS GENERATED FROM THE PROCEDURE OR USAGE OF THE DEVICE. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE NOTED DAMAGE WAS LIKELY DUE TO HANDLING OF THE DEVICE DURING AN ATTEMPT TO DEPLOY THE STENT. IT IS ALSO LIKELY THAT THE STICKY TRANSPARENT RESIDUE CAUSED RESISTANCE DURING DEPLOYMENT OF THE STENT. HOWEVER, WHETHER THE RESIDUE WAS GENERATED FROM THE PROCEDURE OR USAGE OF THE DEVICE REMAINS UNKNOWN, THEREFORE THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX' BILIARY STENT WITH NAVIFLEX' RX DELIVERY SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2011 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SUTURE WOULD NOT RELEASE AND THE STENT WOULD NOT DEPLOY IN THE COMMON BILE DUCT. THE SCOPE CHANNEL WAS REPORTED AS 3.7. THE GUIDEWIRE WAS IN THE PATIENT AND IN THE DELIVERY SYSTEM AT THE TIME OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH AN RX STENT (BSC). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. INVESTIGATIONS RESULTS REVEALED THE PUSH CATHETER TO BE BROKEN, THEREFORE THIS IS NOW AN MDR REPORTABLE EVENT.

    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 M00534320 14058653

    Patients

    Seq Age Sex Outcome Treatment
    1