BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANIX? BILIARY

    MDR report key: 3851525 · Received June 5, 2014

    Report

    Report Number
    3005099803-2014-02110
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND OUT THAT THE GUIDE CATHETER AND THE SUTURE WERE DETACHED. THE GUIDE CATHETER AND THE PULL WIRE WERE BENT. THE NOTED DAMAGE IS LIKELY DUE TO PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING THE PROCEDURE SUCH AS TORTUOUS ANATOMY OR MANEUVERING 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. A REVIEW OF THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) SHOWED THE DEVICE WAS USED ACCORDING TO ITS LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PRELOADED BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THEY PULLED OUT THE PUSHER, THE GUIDE CATHETER DETACHED FROM THE PUSHER AND WAS LEFT INSIDE THE STENT. THE PHYSICIAN RETRIEVED THE BROKEN PART OF THE GUIDE CATHETER USING A RAT-TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED WITH THIS 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PRELOADED BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THEY PULLED OUT THE PUSHER, THE GUIDE CATHETER DETACHED FROM THE PUSHER AND WAS LEFT INSIDE THE STENT. THE PHYSICIAN RETRIEVED THE BROKEN PART OF THE GUIDE CATHETER USING A RAT-TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED WITH THIS 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328996 ADVANIX? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00534700 16060087

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention