BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 2151889 · Received July 6, 2011

    Report

    Report Number
    3005099803-2011-02262
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE SUTURE HOLE ON THE PUSH CATHETER WAS TORN. THE SUTURE WAS DETACHED/SEPARATED AND WAS NOT RETURNED FOR EVALUATION. THE PUSH CATHETER WAS KINKED AT MULTIPLE LOCATIONS THROUGHOUT ITS WORKING LENGTH AND ALSO APPEARED CUT (BROKEN) BY THE CUSTOMER NEAR THE MIDDLE. THE GUIDE CATHETER WAS STRETCHED AND BROKEN CLOSE TO THE PROXIMAL END NEAR THE DISTAL TIP. THE DISTAL WORKING LENGTH OF THE GUIDE CATHETER WAS HAD MULTIPLE KINKS/BENDS (SUTURE IMPRESSIONS). THE PROXIMAL BROKEN PIECE OF THE GUIDE CATHETER WITH THE HUB AND STENT WERE NOT RETURNED FOR EVALUATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT SYSTEM WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) STENTING PROCEDURE IN THE COMMON BILE DUCT OF (B)(6) OLD FEMALE PATIENT (PATIENT WEIGHT IS UNKNOWN). DURING THE PROCEDURE, THE GUIDE CATHETER BROKE AS IT WAS RETRACTED FOR STENT DEPLOYMENT. THE GUIDE AND PUSH CATHETERS WERE CUT NEAR THE HUB TO ACCESS THE BROKEN GUIDE CATHETER. THE BROKEN GUIDE CATHETER WITH THE ATTACHED STENT WAS ADVANCED TO THE TARGET SITE VIA RAT TOOTH. THE STENT WAS PLACED AT THE TARGET SITE AND THE GUIDE CATHETER WAS REMOVED FROM THE PATIENT. 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 BILIARY STENT SYSTEM WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) STENTING PROCEDURE IN THE COMMON BILE DUCT OF A (B)(6) FEMALE PATIENT (PATIENT WEIGHT IS UNKNOWN). DURING THE PROCEDURE, THE GUIDE CATHETER BROKE AS IT WAS RETRACTED FOR STENT DEPLOYMENT. THE GUIDE AND PUSH CATHETERS WERE CUT NEAR THE HUB TO ACCESS THE BROKEN GUIDE CATHETER. THE BROKEN GUIDE CATHETER WITH THE ATTACHED STENT WAS ADVANCED TO THE TARGET SITE VIA RAT TOOTH. THE STENT WAS PLACED AT THE TARGET SITE AND THE GUIDE CATHETER WAS REMOVED FROM THE PATIENT. 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 BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00539230 13612492

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR RAT TOOTH FORCEPS