BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX? BILIARY

    MDR report key: 3905480 · Received July 1, 2014

    Report

    Report Number
    3005099803-2014-02349
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 15, 2014
    Report Date
    June 11, 2014
    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

    PATIENT REPORTED TO BE OVER 18 YEARS OF AGE. EVENT REVEALED BY THE INVESTIGATION OF STENT TORN. THE INVESTIGATION FOUND OUT THAT THE STENT HAD SMALL TEARS ON THE PROXIMAL END AND WAS BENT/KINKED IN SEVERAL PLACES THROUGHOUT. THE NOTED DAMAGE IS LIKELY DUE TO PROCEDURAL/ANATOMICAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH MAY HAVE LIMITED THE OVERALL PERFORMANCE OF THE DEVICE, THEREFORE THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; 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 AN ADVANIX BILIARY DOUBLE PIGTAIL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS STRONG RESISTANCE WHEN THE PHYSICIAN TRIED TO RELEASE THE STENT. THE PHYSICIAN PULLED THE DEVICE WITH STRONG FORCE, THUS, SEPARATING THE INNER CATHETER. THE BROKEN INNER CATHETER DID NOT REMAIN IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY DOUBLE PIGTAIL STENT. 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. INVESTIGATION RESULTS REVEALED THE STENT TO BE TORN, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385022 ADVANIX? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00532190 16769486

    Patients

    Seq Age Sex Outcome Treatment
    1