BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFICATION TO CONTOUR POLARIS URETERAL STENT

    MDR report key: 2082262 · Received May 9, 2011

    Report

    Report Number
    3005099803-2011-01593
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FAD
    PMA / PMN Number
    K030503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED POLARIS ULTRA URETERAL STENT REVEALED THAT THE PROXIMAL END OF THE STENT DETACHED. THE DETACHED FRAGMENT WAS RETURNED. THE SUTURE WAS ALSO RETURNED AND REMAINED ATTACHED AND ENTANGLED AROUND THE PROXIMAL END OF THE STENT. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR POLARIS URETERAL STENT WAS USED IN A URETERAL STENT REPLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, "THE PHYSICIAN EXPERIENCED RESISTANCE WHEN INSERTING THE STENT THROUGH THE GUIDEWIRE." THE STENT WAS THEN WITHDRAWN AND THE PIGTAIL ON THE STENT WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, WITH NO COMPLICATIONS TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTEDLY "GOOD."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR POLARIS URETERAL STENT WAS USED IN A URETERAL STENT REPLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, "THE PHYSICIAN EXPERIENCED RESISTANCE WHEN INSERTING THE STENT THROUGH THE GUIDEWIRE." THE STENT WAS THEN WITHDRAWN AND THE PIGTAIL ON THE STENT WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, WITH NO COMPLICATIONS TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTEDLY 'GOOD.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODIFICATION TO CONTOUR POLARIS URETERAL STENT STENT, URETERAL FAD BOSTON SCIENTIFIC - SPENCER M006192132090 0013502453

    Patients

    Seq Age Sex Outcome Treatment
    1