BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS LOOP URETERAL STENT

    MDR report key: 832155 · Received March 26, 2007

    Report

    Report Number
    6000043-2007-00031
    Event Type
    Injury
    Date Received
    March 26, 2007
    Date of Event
    February 26, 2007
    Report Date
    February 27, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FAD
    PMA / PMN Number
    k030503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SHIP HISTORY WAS PERFORMED WHICH IDENTIFIED THE LAST THREE LOT NUMBERS THAT WERE SENT TO THIS CUSTOMER. LOT NUMBERS: 915300, 8956427 AND 8741707. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST THE THREE IDENTIFIED LOTS. A PRODUCT HISTORY SEARCH WAS PERFORMED AND FOUND TWO SIMILAR COMPLAINTS AGAINST THE UPN FROM THE SAME CUSTOMER. IN ADDITION, THE FEBRUARY 2007 15-MONTH COMPLAINT TREND REPORT FOR ALL POLARIS LOOP FAMILY FAILURE MODES WAS REVIEWED; THE PRODUCT FAMILY IS EXCEEDING THE BSC ACTION LIMIT, BUT DOES SHOW A NEGATIVE TREND AT THIS TIME. VISUAL EXAMINATION FOUND ONE DISTAL LOOP WAS CUT IN TWO AND THE SECOND HAD BEEN PARTIALLY CUT THROUGH. THE ENDS AT THE BREAK WERE FOUND TO BE ANGLED. THE CUSTOMER'S COMPLAINT HAS BEEN CONFIRMED. THE ROOT CAUSE APPEARS TO BE DUE TO REMOVAL OF THE SUTURE. THE MOST PROBABLE ROOT CAUSE APPEARS TO BE DUE TO THE SUTURE BEING PULLED ON WHILE CUTTING THE SUTURE, WHICH IN TURN CUT ONE LOOP AT AN ANGLE AND THE OTHER PARTIALLY OR THE SUTURE MIGHT HAVE BEEN CUT AND PULLED THROUGH THE LOOPS TO RELEASE A FREE END CAUSING A SAWING ACTION ON THE LOOPS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BSC THAT A FEMALE PATIENT (AGE UNKNOWN) HAD BILATERAL URETERAL STENTS PLACED IN 2006. ON THE EVENT DAY, THE PATIENT PRESENTED WITH "DISCOMFORT." THE PATIENT THEN UNDERWENT A THERAPEUTIC PROCEDURE TO REPLACE BOTH POLARIS LOOP STENTS. THE CLINICIAN REPORTED THAT THE POLARIS LOOP STENTS HAD "SEPARATED IN TWO PIECES - DIRECTLY IN HALF." PLEASE NOTE ASSOCIATED MEDWATCH REPORT #: 6000043-2007-00030. THERE WAS NO MIGRATION OF ANY COMPONENT. UPON REPLACEMENT OF THE POLARIS LOOP STENT, IT WAS REPORTED THAT THE SAME ISSUE (BREAKAGE OF STENT) WAS NOTED TO THE REPLACEMENT STENT. THIS DEVICE WAS REMOVED. PLEASE NOTE ASSOCIATED MEDWATCH REPORT #: 6000043-2007-00032. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT DID NOT SUSTAIN ANY ADVERSE EFFECT OR COMPLICATIONS AS A RESULT OF THIS ISSUE. THE PATIENT CONDITION IS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS LOOP URETERAL STENT FAD FAD BOSTON SCIENTIFIC M0061552410 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention