BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANIX¿ BILIARY

    MDR report key: 2834066 · Received November 15, 2012

    Report

    Report Number
    3005099803-2012-05223
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 21, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF GUIDE CATHETER BROKEN. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. 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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT GUIDE CATHETER WAS BENT AND HAD SEPARATED FROM THE REST OF THE DELIVERY SYSTEM. THE PULL WIRE WAS FULLY RETRACTED. THE PULL WIRE CANNULA WAS INSPECTED AND THERE WERE NO PARTS OF THE GUIDE CATHETER STILL ATTACHED. THE GUIDE CATHETER HAD SEPARATED FROM THE PULL WIRE CANNULA; HOWEVER THE WORKING LENGTH OF THE GUIDE CATHETER WAS INTACT. THE NOTED DAMAGES INDICATE DIFFICULTY WAS EXPERIENCED DURING DEPLOYMENT AND ARE LIKELY DUE TO ANATOMICAL OR PROCEDURAL FACTORS SUCH AS TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. A REVIEW OF THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) WAS PERFORMED AND NO ANOMALIES WERE NOTED.

    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 COMMON BILE DUCT PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN DEPLOYED THE STENT THE GUIDE CATHETER BROKE AND STAYED IN THE STENT. THE REST OF THE DELIVERY SYSTEM WAS REMOVED AND THE BROKEN GUIDE CATHETER WAS REMOVED FROM THE PATIENT WITH RAT TOOTH FORCEPS. 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.

    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 COMMON BILE DUCT PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN DEPLOYED THE STENT THE GUIDE CATHETER BROKE AND STAYED IN THE STENT. THE REST OF THE DELIVERY SYSTEM WAS REMOVED AND THE BROKEN GUIDE CATHETER WAS REMOVED FROM THE PATIENT WITH RAT TOOTH FORCEPS. 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
    1 ADVANIX¿ BILIARY BILIARY CATHETERS AND ACCESSORIES FGE BOSTON SCIENTIFIC - SPENCER M00534330 15430620

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention