BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFICATION TO CONTOUR POLARIS URETERAL STENT

    MDR report key: 2122331 · Received June 13, 2011

    Report

    Report Number
    3005099803-2011-01954
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Report Date
    May 19, 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

    COMPONENT (B)(4) RELATES TO DEVICE (B)(4) FOR SUTURE BREAK. COMPONENT (B)(4) RELATES TO DEVICE (B)(4) FOR ENTRAPMENT. COMPONENT (B)(4) RELATES TO DEVICE (B)(4) FOR TORN MATERIAL. (B)(6).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED POLARIS URETERAL STENT REVEALED THAT THE STENT WAS TORN FROM THE SUTURE HOLE TO THE PROXIMAL END OF THE STENT. THE SUTURE WAS NOT PRESENT WITH THE RETURNED DEVICE. MOST LIKELY, THE SUTURE TORE THROUGH THE STENT WHILE ATTEMPTING TO WITHDRAW THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A TRANSURETHERAL URETERO-LITHOTRIPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING POSITIONED AFTER THE TRANSURETHERAL URETERO-LITHOTRIPSY PROCEDURE. A STONE WAS STUCK IN THE ANATOMY, AND THE STENT WAS ADVANCED PAST THE STUCK STONE. WHEN WITHDRAWING THE GUIDEWIRE FROM THE STENT DURING PLACEMENT, THE GUIDEWIRE BECAME STUCK WITHIN THE STENT. WHEN FORCE WAS APPLIED TO WITHDRAW THE DEVICE, THE DISTAL END OF THE STENT TORE, BETWEEN THE SUTURE HOLE AND THE PROXIMAL TIP. ADDITIONALLY, THE SUTURE BROKE WHEN THE STENT WAS BEING REMOVED. THE STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED 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 "GOOD."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A TRANSURETHERAL URETERO-LITHOTRIPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING POSITIONED AFTER THE TRANSURETHERAL URETERO-LITHOTRIPSY PROCEDURE. A STONE WAS STUCK IN THE ANATOMY, AND THE STENT WAS ADVANCED PAST THE STUCK STONE. WHEN WITHDRAWING THE GUIDEWIRE FROM THE STENT DURING PLACEMENT, THE GUIDEWIRE BECAME STUCK WITHIN THE STENT. WHEN FORCE WAS APPLIED TO WITHDRAW THE DEVICE, THE DISTAL END OF THE STENT TORE, BETWEEN THE SUTURE HOLE AND THE PROXIMAL TIP. ADDITIONALLY, THE SUTURE BROKE WHEN THE STENT WAS BEING REMOVED. THE STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS' CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "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 M0061921330 13961817

    Patients

    Seq Age Sex Outcome Treatment
    1