BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX BILIARY

    MDR report key: 2162186 · Received July 14, 2011

    Report

    Report Number
    3005099803-2011-02302
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED; HOWEVER THE EVALUATION HAS NOT YET BEEN COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE GUIDE CATHETER WAS DETACHED/SEPARATED FROM THE PULL WIRE AND WAS KINKED AT MULTIPLE LOCATIONS. THE WORKING LENGTH OF GUIDE CATHETER WAS FOUND INTACT (UNBROKEN). THE PROXIMAL END OF THE GUIDE CATHETER THAT ATTACHES TO THE WELDED CANNULA/PULL WIRE ASSEMBLY WAS FREE OF SPLITS/TEARS. THE OVERALL LENGTH OF THE GUIDE CATHETER MET SPECIFICATION OF 32.0 CM (MINIMUM). THE PULL WIRE WAS BENT AT THE PROXIMAL END. THE WHITE MOLDED HANDLE WAS DETACHED FROM THE PULL WIRE. THE PROXIMAL TIP OF THE PULL WIRE WAS BENT WHICH INDICATED THAT THE MOLDED HANDLE WAS SECURELY ATTACHED DURING MANUFACTURING. THE WELDED CANNULA/PULL WIRE WAS FREE OF DAMAGE. BASED ON THE CONDITION OF THE DEVICE AND THE DETAILS OF THE EVENT, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. 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.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION RECEIVED SINCE (B)(6), 2011: THE OVERALL LENGTH OF THE GUIDE CATHETER MEASURED APPROXIMATELY 32.8 CM WHICH DOES NOT MEET THE GUIDE CATHETER CUT LENGTH SPECIFICATION OF 32.0CM +/- 1MM. THE INCREASED LENGTH OF THE GUIDE CATHETER IS DUE TO KINKS IN ITS WORKING LENGTH; THE KINKS FLATTEN THE GUIDE CATHETER ASSEMBLY CAUSING THE OVERALL INTEGRITY TO BE COMPROMISED. IT WAS ORIGINALLY REPORTED THAT THE OVERALL LENGTH OF THE GUIDE CATHETER MET SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT SYSTEM WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ABOVE BIFURCATION OF THE HEPATIC DUCT OF A (B)(6) OLD MALE PATIENT WEIGHING (B)(6). DURING THE PROCEDURE, AS THE PULLWIRE WAS RETRACTED FOR STENT DEPLOYMENT, THE PULLWIRE BROKE IN HALF AND THE GUIDE CATHETER DETACHED FROM DELIVERY SYSTEM. THE PULLWIRE WAS THEN PULLED ALL THE WAY OUT OF THE CATHETER. THE DETACHED GUIDE CATHETER REMAINED IN THE DEPLOYED STENT INSIDE THE PATIENT. THE GUIDE CATHETER WAS RETRACTED FROM THE PATIENT WITH A SNARE AND THE STENT WAS LEFT INSIDE THE PATIENT AT THE TARGET SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE FINE AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT SYSTEM WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ABOVE BIFURCATION OF THE HEPATIC DUCT OF A (B)(6) OLD MALE PATIENT WEIGHING (B)(6). DURING THE PROCEDURE, AS THE PULLWIRE WAS RETRACTED FOR STENT DEPLOYMENT, THE PULLWIRE BROKE IN HALF AND THE GUIDE CATHETER DETACHED FROM DELIVERY SYSTEM. THE PULLWIRE WAS THEN PULLED ALL THE WAY OUT OF THE CATHETER. THE DETACHED GUIDE CATHETER REMAINED IN THE DEPLOYED STENT INSIDE THE PATIENT. THE GUIDE CATHETER WAS RETRACTED FROM THE PATIENT WITH A SNARE AND THE STENT WAS LEFT INSIDE THE PATIENT AT THE TARGET SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE FINE AFTER THE PROCEDURE. ON (B)(6), 2011, THE COMPLAINANT CLARIFIED THE PULLWIRE DID NOT BREAK IN HALF.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA RX BILIARY STENT SYSTEM WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ABOVE BIFURCATION OF THE HEPATIC DUCT OF A (B)(6) MALE PATIENT WEIGHING (B)(6). DURING THE PROCEDURE, AS THE PULLWIRE WAS RETRACTED FOR STENT DEPLOYMENT, THE PULLWIRE BROKE IN HALF AND THE GUIDE CATHETER DETACHED FROM DELIVERY SYSTEM. THE PULLWIRE WAS THEN PULLED ALL THE WAY OUT OF THE CATHETER. THE DETACHED GUIDE CATHETER REMAINED IN THE DEPLOYED STENT INSIDE THE PATIENT. THE GUIDE CATHETER WAS RETRACTED FROM THE PATIENT WITH A SNARE AND THE STENT WAS LEFT INSIDE THE PATIENT AT THE TARGET SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00545590 14160672

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention