BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFICATION TO CONTOUR POLARIS URETERAL STENT

    MDR report key: 2023300 · Received March 18, 2011

    Report

    Report Number
    3005099803-2011-00743
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    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

    ALTHOUGH EXPECTED, THE DEVICE AT ISSUE IN THIS COMPLAINT HAS NOT YET BEEN RECEIVED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE RETURNED POLARIS ULTRA URETERAL STENT REVEALED THE PROXIMAL END OF THE STENT WAS DETACHED. THE STENT WAS TORN APPROXIMATELY 4.6CM FROM THE PROXIMAL END. THE PROXIMAL END OF THE STENT WAS DETACHED. THE DETACHED FRAGMENT WAS RETURNED. THE SUTURE WAS PRESENT AND ATTACHED TO THE DETACHED FRAGMENT OF THE STENT. THE SUTURE HOLE WAS STRETCHED. THE TEAR IS CONSISTENT WITH THOSE CAUSED BY THE SUTURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS DETERMINED TO BE HANDLING DAMAGE. IT IS ALSO NOTED THAT STENT DAMAGE, PRIOR TO PLACEMENT DUE TO HANDLING DAMAGE, IS NOT A MEDWATCH REPORTABLE CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR POLARIS URETERAL STENT WAS USED IN A URETEROSCOPY PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PIGTAIL WAS NOTICED TO BE BROKEN DURING UNPACKING. DEVICE WAS NOT USED AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME DEVICE. 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 "STABLE". SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL EVENT INFORMATION. HOWEVER, NO FURTHER EVENT DETAILS HAVE BEEN MADE AVAILABLE TO BOSTON SCIENTIFIC TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR POLARIS URETERAL STENT WAS USED IN A URETEROSCOPY PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PIGTAIL WAS NOTICED TO BE BROKEN DURING UNPACKING. DEVICE WAS NOT USED AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME DEVICE. 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 "STABLE". SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL EVENT INFORMATION. HOWEVER, NO FURTHER EVENT DETAILS HAVE BEEN MADE AVAILABLE TO BOSTON SCIENTIFIC TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODIFICATION TO CONTOUR POLARIS URETERAL STENT STENT, URETERAL FAD BOSTON SCIENTIFIC - SPENCER M0061921230 13539594

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR