BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFICATION TO CONTOUR POLARIS URETERAL STENT

    MDR report key: 2173547 · Received July 23, 2011

    Report

    Report Number
    3005099803-2011-02441
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FAD
    PMA / PMN Number
    K030503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED POLARIS LOOP URETERAL STENT REVEALED THAT THE DISTAL TIP WAS TORN APPROXIMATELY 2MM FROM THE END, AND IT WAS ALSO FLATTENED/KINKED. A .038 GUIDEWIRE PASSED FREELY THROUGH THE STENT. A PIECE OF THE SUTURE WAS PRESENT WITH THE RETURN AND ATTACHED TO THE PROXIMAL LOOPS. IT IS POSSIBLE THAT THE SUTURE TORE THE END OF THE STENT OR SOME SHARP OBJECT CUT THE STENT DURING THE PROCEDURE, BUT THIS COULD NOT BE DETERMINED. OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PROCEDURE TO PLACE A POLARIS LOOP URETERAL STENT USING URETEROSCOPY, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE STENT INSIDE THE PATIENT WITH THE POSITIONER. THE PHYSICIAN THEN USED FLUOROSCOPY, AND DETERMINED THAT THE STENT WAS BUCKLING AND THERE WAS A SLIT ON THE PROXIMAL END OF THE STENT. REPORTEDLY, THE PHYSICIAN HAD REMOVED THE SUTURE, AND KEPT THE STENT WET DURING THE PROCEDURE. THE PATIENT DID NOT HAVE A DIFFICULT ANATOMY, AND NO DEFICIENCIES WERE NOTED WITH THE SENSOR GUIDEWIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PROCEDURE TO PLACE A POLARIS LOOP URETERAL STENT USING URETEROSCOPY, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE STENT INSIDE THE PATIENT WITH THE POSITIONER. THE PHYSICIAN THEN USED FLUOROSCOPY, AND DETERMINED THAT THE STENT WAS BUCKLING AND THERE WAS A SLIT ON THE PROXIMAL END OF THE STENT. REPORTEDLY, THE PHYSICIAN HAD REMOVED THE SUTURE, AND KEPT THE STENT WET DURING THE PROCEDURE. THE PATIENT DID NOT HAVE A DIFFICULT ANATOMY, AND NO DEFICIENCIES WERE NOTED WITH THE SENSOR GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER POLARIS LOOP URETERAL STENT, WITH NO COMPLICATIONS TO THE PATIENT, WHO WAS REPORTEDLY "FINE" 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 - COSTA RICA M0061552210 0013766606

    Patients

    Seq Age Sex Outcome Treatment
    1