BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE?

    MDR report key: 3913230 · Received July 3, 2014

    Report

    Report Number
    3005099803-2014-02462
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER 18 YEARS OLD. THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #S 3005099803-2014-02462, 3005099803-2014-02445 AND 3005099803-2014-02469 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT, A TANDEM CANNULA, AND A JAGWIRE GUIDEWIRE WERE USED IN THE RECTUM DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS IMPLANTED TO TREAT A STRICTURE 6 CM FROM THE ENTRANCE OF THE RECTUM. REPORTEDLY, THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A JAGWIRE GUIDEWIRE AND A TANDEM WERE ADVANCED TO THE LESION AND CONTRAST RADIOGRAPHY WAS PERFORMED. THE PHYSICIAN REMOVED THE TANDEM AND ADVANCED THE WALLFLEX ENTERAL COLONIC STENT TO THE STRICTURE. THE STENT WAS ABLE TO ADVANCE 1CM INTO THE STENOSIS BUT THEN RESISTANCE WAS FELT. THE PHYSICIAN ATTEMPTED TO FURTHER ADVANCE THE STENT BY SLIGHTLY PULLING THE GUIDEWIRE WHILE ADVANCING THE STENT. IT WAS THEN REPORTED THAT A PERFORATION WAS NOTED IN THE INTESTINAL TRACT. THE JAGWIRE GUIDEWIRE AND WALLFLEX ENTERAL COLONIC STENT WERE REMOVED FROM THE PATIENT. THE PHYSICIAN INSERTED A TANDEM AND PERFORMED RADIOGRAPHY USING UROGRAFIN WHICH SHOWED THE ABDOMINAL CAVITY. IT WAS REPORTED THAT AN EMERGENCY OPERATION WAS PERFORMED. DESPITE NUMEROUS ATTEMPTS BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-02462, 3005099803-2014-02445 AND 3005099803-2014-02469 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT, A TANDEM CANNULA, AND A JAGWIRE GUIDEWIRE WERE USED IN THE RECTUM DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS IMPLANTED TO TREAT A STRICTURE 6 CM FROM THE ENTRANCE OF THE RECTUM. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A JAGWIRE GUIDEWIRE AND A TANDEM WERE ADVANCED TO THE LESION AND CONTRAST RADIOGRAPHY WAS PERFORMED. THE PHYSICIAN REMOVED THE TANDEM AND ADVANCED THE WALLFLEX ENTERAL COLONIC STENT TO THE STRICTURE. THE STENT WAS ABLE TO ADVANCE 1CM INTO THE STENOSIS BUT THEN RESISTANCE WAS FELT. THE PHYSICIAN ATTEMPTED TO FURTHER ADVANCE THE STENT BY SLIGHTLY PULLING THE GUIDEWIRE WHILE ADVANCING THE STENT. IT WAS THEN REPORTED THAT A PERFORATION WAS NOTED IN THE INTESTINAL TRACT. THE JAGWIRE GUIDEWIRE AND WALLFLEX ENTERAL COLONIC STENT WERE REMOVED FROM THE PATIENT. THE PHYSICIAN INSERTED A TANDEM AND PERFORMED RADIOGRAPHY USING UROGRAFIN WHICH SHOWED THE ABDOMINAL CAVITY. IT WAS REPORTED THAT AN EMERGENCY OPERATION WAS PERFORMED. ADDITIONAL INFORMATION RECEIVED ON JULY 6, 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS IMPLANTED TO TREAT A 4 CM MALIGNANT STRICTURE IN THE RECTUM DUE TO COLON CANCER. IN THE PHYSICIAN'S ASSESSMENT, THE WALLFLEX ENTERAL COLONIC STENT AND JAGWIRE GUIDEWIRE CAUSED THE PERFORATION AND THE TANDEM XL ERCP CANNULA WAS NOT ASSOCIATED WITH THE PERFORATION. THE PATIENT WAS SENT TO SURGERY TO TREAT THE PERFORATION. IT WAS REPORTED "DURING SURGERY FOR PERFORATION, IT WAS NOTICED DAMAGE TO THE URETER." IT IS UNKNOWN WHETHER THE STENT OR THE GUIDEWIRE CONTRIBUTED TO THE DAMAGE IN THE URETER. ADDITIONALLY, NO ISSUES WITH THE STENT, GUIDEWIRE AND CANNULA WERE SEEN DURING USE. ADDITIONAL INFORMATION RECEIVED ON AUGUST 10, 2014. THE LOCATION OF THE PERFORATION WAS CLARIFIED TO HAVE BEEN IN THE RECTUM ABOVE THE PERITONEAL REFLECTION. IN THE PHYSICIAN'S ASSESSMENT, THE DAMAGE TO THE URETER WAS RELATED TO THE STENT DELIVERY SYSTEM.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-02445 AND 3005099803-2014-02469 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT, A TANDEM CANNULA, AND A JAGWIRE GUIDEWIRE WERE USED IN THE RECTUM DURING A STENT PLACEMENT PROCEDURE PERFORMED ON JUNE 12, 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS IMPLANTED TO TREAT A STRICTURE 6 CM FROM THE ENTRANCE OF THE RECTUM. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A JAGWIRE GUIDEWIRE AND A TANDEM WERE ADVANCED TO THE LESION AND CONTRAST RADIOGRAPHY WAS PERFORMED. THE PHYSICIAN REMOVED THE TANDEM AND ADVANCED THE WALLFLEX ENTERAL COLONIC STENT TO THE STRICTURE. THE STENT WAS ABLE TO ADVANCE 1CM INTO THE STENOSIS BUT THEN RESISTANCE WAS FELT. THE PHYSICIAN ATTEMPTED TO FURTHER ADVANCE THE STENT BY SLIGHTLY PULLING THE GUIDEWIRE WHILE ADVANCING THE STENT. IT WAS THEN REPORTED THAT A PERFORATION WAS NOTED IN THE INTESTINAL TRACT. THE JAGWIRE GUIDEWIRE AND WALLFLEX ENTERAL COLONIC STENT WERE REMOVED FROM THE PATIENT. THE PHYSICIAN INSERTED A TANDEM AND PERFORMED RADIOGRAPHY USING UROGRAFIN WHICH SHOWED THE ABDOMINAL CAVITY. IT WAS REPORTED THAT AN EMERGENCY OPERATION WAS PERFORMED. DESPITE NUMEROUS ATTEMPTS BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONALLY, THIS DEVICE IS NOT INDICATED FOR USE IN THE RECTUM, IT IS USED TO INJECT CONTRAST MEDIUM TO OBTAIN A CHOLANGIOGRAM OF THE BILIARY DUCT SYSTEM. ADDITIONAL INFORMATION RECEIVED ON JULY 6, 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS IMPLANTED TO TREAT A 4 CM MALIGNANT STRICTURE IN THE RECTUM DUE TO COLON CANCER. IN THE PHYSICIAN'S ASSESSMENT, THE WALLFLEX ENTERAL COLONIC STENT AND JAGWIRE GUIDEWIRE CAUSED THE PERFORATION AND THE TANDEM XL ERCP CANNULA WAS NOT ASSOCIATED WITH THE PERFORATION. THE PATIENT WAS SENT TO SURGERY TO TREAT THE PERFORATION. IT WAS REPORTED "DURING SURGERY FOR PERFORATION, IT WAS NOTICED DAMAGE TO THE URETER." IT IS UNKNOWN WHETHER THE STENT OR THE GUIDEWIRE CONTRIBUTED TO THE DAMAGE IN THE URETER. ADDITIONALLY, NO ISSUES WITH THE STENT, GUIDEWIRE AND CANNULA WERE SEEN DURING USE. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THE URETER DAMAGE TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389727 JAGWIRE? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00556591

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention