BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 1933972 · Received December 21, 2010

    Report

    Report Number
    3005099803-2010-05172
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE SUTURE WAS MISSING FROM THE PUSH CATHETER. THE PUSH CATHETER SUTURE HOLE HAD A SLIGHT TEAR TOWARD THE DISTAL END. THE GUIDE CATHETER WAS BROKEN INTO 2 SECTIONS. THE DISTAL PORTION OF THE GUIDE CATHETER WAS KINKED, STRETCHED, AND WITH A SUTURE IMPRESSION. THE PROXIMAL PORTION WAS STRETCHED, ACCORDIONED AND STUCK ONTO THE GUIDEWIRE. BASED ON THE CONDITION OF THE DEVICE AND THE DETAILS OF THE EVENT, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN, BUT IS REPORTEDLY OVER 18 YEARS. 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-05275 ADDRESSES THE OTHER DEVICE USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT SYSTEM AND A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6) 2010 DURING THE PROCEDURE, THE PROXIMAL END OF THE GUIDE CATHETER OF THE FLEXIMA BILIARY STENT SYSTEM BROKE, HOWEVER THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT AT THE TARGET SITE. THE DISTAL END OF THE GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ALLOWING THE DEVICE TO BE REMOVED IN ONE PIECE. NO FRAGMENTS OF THE GUIDE CATHETER DEVICE FELL INTO THE PATIENT. 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 AND STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-05275 ADDRESSES THE OTHER DEVICE USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT SYSTEM AND A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6), 2010 DURING THE PROCEDURE, THE PROXIMAL END OF THE GUIDE CATHETER OF THE FLEXIMA BILIARY STENT SYSTEM BROKE, HOWEVER THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT AT THE TARGET SITE. THE DISTAL END OF THE GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ALLOWING THE DEVICE TO BE REMOVED IN ONE PIECE. NO FRAGMENTS OF THE GUIDE CATHETER DEVICE FELL INTO THE PATIENT. 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 AND STABLE.

    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 M00539260

    Patients

    Seq Age Sex Outcome Treatment
    1