BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS LOOP URETERAL STENT

    MDR report key: 834988 · Received March 26, 2007

    Report

    Report Number
    6000043-2007-00032
    Event Type
    Malfunction
    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
    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 INDENTIFIED 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 INDENTIFIED LOTS. A PRODUCT HISTORY SEARCH WAS PERFORMED AND FOUND TWO SIMILAR COMPLAINTS AGAINST THE UPN NUMBER FOR THE SAME ISSUE FROM THE SAME CUSTOMER. THE ROOT CAUSE CLASSIFICATION COULD NOT BE DETERMINED. IN ADDITION, THE FEBRUARY 2007 15-MONTHS 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.

    Description of Event or Problem · 1

    PLEASE NOTE: DATA OF INITIAL PLACEMENT OF THE STENTS WAS IN 2006. THE COMPLAINANT HAS REPORTED THAT A FEMALE PATIENT (AGE UNKNOWN) UNDERWENT A THERAPEUTIC PROCEDURE TO REPLACE BILATERAL URETERAL STENTS ON THE FOLLOWING YEAR. UPON DEPLOYMENT OF THE REPLACEMENT POLARIS LOOP STENT, THE CLINICIAN NOTED THAT THE STENT HAD SEPARATED "IN THE MIDDLE OF THE DEVICE BETWEEN THE LOOPS". THE DEVICE WAS REMOVED AND DISPOSED OF. 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 *