BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFICATION TO CONTOUR POLARIS URETERAL STENT

    MDR report key: 1842366 · Received September 23, 2010

    Report

    Report Number
    3005099803-2010-03954
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FAD
    PMA / PMN Number
    K030503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CAN NOT BE DETERMINED. THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MANUFACTURER'S REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED POLARIS' ULTRA STENT REVEALED THE STENT WAS TORN ON THE PROXIMAL END. THE PROXIMAL END OF THE STENT WAS STILL ATTACHED. THE TEAR IN THE STENT STARTS AT THE SUTURE HOLE ON THE PROXIMAL END OF THE DEVICE. THE TEAR IS CONSISTENT WITH THOSE CAUSED BY THE SUTURE WHEN TRYING TO TUG ON THE SUTURE WHILE ATTACHED TO THE STENT. THE FORCE REQUIRED TO TEAR THE STENT WITH THE SUTURE WAS LESS THAN THE FORCE REQUIRED TO WITHDRAW THE STENT FROM THE PATIENT. ADDITIONALLY, THE EVENT DESCRIPTION STATES "THE STENT HAD BEEN IMPLANTED FOR ABOUT TWO WEEKS IN THE PATIENT". THE DIRECTIONS FOR STENT REMOVAL STATES, "[SUTURE] MAY BE USED FOR SUBSEQUENT STENT REMOVAL (NOT RECOMMENDED FOR LONG-TERM STENTING EXCEEDING TWO WEEKS). THIS CASE MAY HAVE BEEN INDWELL TO THE POINT WHERE THE SUTURE WAS NOT THE BEST METHOD FOR REMOVING THE STENT. SINCE THE EVENT OCCURRED DURING THE PROCEDURE TO REMOVE THE STENT, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS DETERMINED TO BE OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS' ULTRA STENT WAS IMPLANTED IN A PATIENT FOR APPROXIMATELY TWO WEEKS. ACCORDING TO THE COMPLAINANT, THE STENT WAS TORN AT ROOF OF THE BLADDER WHEN THE PHYSICIAN ATTEMPTED TO REMOVE IT AFTER ESWL. THE STENT WAS REMOVED DURING THE SAME PROCEDURE USING FORCEPS. THE PATIENT IS REPORTED TO BE IN "GOOD" CONDITION AT THE CONCLUSION OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS' ULTRA STENT WAS IMPLANTED IN A PATIENT FOR APPROXIMATELY TWO WEEKS. ACCORDING TO THE COMPLAINANT, THE STENT WAS TORN AT ROOF OF THE BLADDER WHEN THE PHYSICIAN ATTEMPTED TO REMOVE IT AFTER ESWL. THE STENT WAS REMOVED DURING THE SAME PROCEDURE USING FORCEPS. THE PATIENT IS REPORTED TO BE IN "GOOD" CONDITION AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODIFICATION TO CONTOUR POLARIS URETERAL STENT STENT, URETERAL FAD BOSTON SCIENTIFIC - SPENCER M0061921330

    Patients

    Seq Age Sex Outcome Treatment
    1