BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANIX¿ BILIARY

    MDR report key: 2933571 · Received January 29, 2013

    Report

    Report Number
    3005099803-2013-00329
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE PATIENT AGE AND DATE OF BIRTH; HOWEVER PATIENT WAS REPORTED TO BE OVER 18 YEARS OLD. THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE.(B)(4).THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PRELOADED BILIARY STENT WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE DUODENUM PERFORMED ON (B)(6), 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN DEPLOYED THE STENT THE GUIDE CATHETER BROKE AND STAYED IN THE STENT. THE ERCP ENDOSCOPE AND REST OF THE DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT AND AN EGD ENDOSCOPE WAS INTRODUCED TO REMOVE THE BROKEN GUIDE CATHETER. THE GUIDE CATHETER WAS SUCCESSFULLY REMOVED AND THE STENT WAS LEFT IN PLACE TO COMPLETE THE PROCEDURE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38759 ADVANIX¿ BILIARY BILIARY CATHETERS AND ACCESSORIES FGE BOSTON SCIENTIFIC - MARLBOROUGH M00534330

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention