BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFICATION TO CONTOUR POLARIS URETERAL STENT

    MDR report key: 2183038 · Received July 28, 2011

    Report

    Report Number
    3005099803-2011-02539
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    July 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    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 LOOP URETERAL STENT REVEALED THAT THE STENT'S LOOPS WERE TORN AT THE MOST PROXIMAL SECTION. WHEN ANALYZING THE RETURNED DEVICE, IT WAS CLEARLY OBSERVED THAT THE SUTURE WAS NOT PRESENT AND THAT THE 2 LOOPS WERE TORN IN THE SAME SECTION. THIS EVIDENCE SUGGESTS THAT A FORCE WAS ACTUALLY APPLIED TO THE SUTURE WHICH CAUSED A TEAR ON THE LOOPS, AND THE SUTURE TO BE PULLED OFF COMPLETELY. THIS WAS MOST LIKELY CAUSED WHILE THE PHYSICIAN WAS MANEUVERING THE STENT INSIDE THE PATIENT AND DUE TO PROCEDURAL/USE FACTORS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOLLOWING PLACEMENT OF A POLARIS LOOP URETERAL STENT, IT WAS DISCOVERED UNDER THE SCOPE IMAGE THAT THE LOOP OF THE STENT WAS TORN. REPORTEDLY, THE SUTURE HAD NOT BEEN REMOVED FROM THE STENT, AND TENSION WAS NOT APPLIED TO THE STENT DURING THE PROCEDURE. 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 FOLLOWING PLACEMENT OF A POLARIS LOOP URETERAL STENT, IT WAS DISCOVERED UNDER THE SCOPE IMAGE THAT THE LOOP OF THE STENT WAS TORN. REPORTEDLY, THE SUTURE HAD NOT BEEN REMOVED FROM THE STENT, AND TENSION WAS NOT APPLIED TO THE STENT DURING THE PROCEDURE. 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 - COSTA RICA M006155231090

    Patients

    Seq Age Sex Outcome Treatment
    1