BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX? BILIARY

    MDR report key: 4932729 · Received July 22, 2015

    Report

    Report Number
    3005099803-2015-02088
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Report Date
    June 26, 2015
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS OF STENT DEFORMED. A VISUAL EVALUATION WAS PERFORMED AND FOUND THE STENT WAS KINKED AND BENT IN SEVERAL LOCATIONS THROUGHOUT. THE PROXIMAL TIP OF THE STENT WAS DEFORMED FROM BEING CRUSHED AGAINST THE DISTAL TIP OF THE PUSH CATHETER. THE PUSH CATHETER WAS BENT IN SEVERAL LOCATIONS, AND WAS BUCKLED AND TORN NEAR THE HANDLE. A FUNCTIONAL EVALUATION FOR STENT DEPLOYMENT WAS PERFORMED AND FOUND THE DEVICE FAILED TO DEPLOY STENT. BASED ON THE PRODUCT ANALYSIS, IT IS LIKELY THAT PROCEDURAL / ANATOMICAL FACTORS WERE ENCOUNTERED DURING THE PROCEDURE WHICH MAY HAVE LIMITED THE OVERALL PERFORMANCE OF THE DEVICE. A DEVICE UNDER TORTUOUS CONDITION DUE TO PATIENT ANATOMY OR CUSTOMER USE/MANIPULATION/MANEUVERING CAN CAUSE THE DEVICE TO BEND/COIL LEADING TO KINKS AND BENDS IN THE CATHETER AND STENT. WITH THE STENT AND CATHETERS BOUND BY KINKS AND BENDS, THE DEVICE COULD BECOME UNABLE TO DEPLOY THE STENT. FORCEFUL ATTEMPT TO DEPLOY THE STENT COULD CAUSE BUCKLING AND TEARING OF THE PUSH CATHETER. THEREFORE, 'OPERATIONAL CONTEXT' IS SELECTED AS THE MOST PROBABLE ROOT CAUSE FOR THE COMPLAINT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED IN AN ENDOSCOPIC BILIARY DRAINAGE (EBD) PROCEDURE PERFORMED IN THE LIVER OF A PATIENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ATTEMPTING TO RELEASE THE STENT. THE SCOPE WAS REPOSITIONED, BUT THE ISSUE WAS NOT RESOLVED. THE PHYSICIAN ATTEMPTED TO CONTINUE RELEASING THE STENT, BUT THE PROXIMAL OUTER SHEATH WAS DEFORMED AND THE STENT COULD NOT BE RELEASED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 "GOOD". THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474857 ADVANIX? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00532190 17670577

    Patients

    Seq Age Sex Outcome Treatment
    1