BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANIX? BILIARY

    MDR report key: 4092930 · Received September 16, 2014

    Report

    Report Number
    3005099803-2014-03121
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOUND OUT THAT THE GUIDE CATHETER WAS DETACHED AND BENT; THE STENT WAS BENT AND THE SUTURE WAS BROKEN. THE NOTED DAMAGE ARE 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 REVIEW OF THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) SHOWED THE DEVICE WAS USED ACCORDING TO ITS LABEL.

    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.

    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 IN THE COMMON BILE DUCT ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SUTURE WOULD NOT RELEASE THE STENT. THEY PULLED BACK TO DEPLOY THE STENT AND THE GUIDE CATHETER BROKE OFF. THE BROKEN PART OF THE GUIDE CATHETER STAYED WITHIN THE STENT INSIDE THE PATIENT AND BOTH COMPONENTS WERE RETRIEVED USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX PRELOADED BILIARY 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 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 IN THE COMMON BILE DUCT ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SUTURE WOULD NOT RELEASE THE STENT. THEY PULLED BACK TO DEPLOY THE STENT AND THE GUIDE CATHETER BROKE OFF. THE BROKEN PART OF THE GUIDE CATHETER STAYED WITHIN THE STENT INSIDE THE PATIENT AND BOTH COMPONENTS WERE RETRIEVED USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX PRELOADED BILIARY 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573595 ADVANIX? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00534340 16951284

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention