BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS? LOOP

    MDR report key: 3181563 · Received June 21, 2013

    Report

    Report Number
    3005099803-2013-05171
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FAD
    PMA / PMN Number
    K030503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION WAS PERFORMED ON THE RETURNED DEVICE AND NO ANOMALIES WERE FOUND. THE CONDITION OF THE RETURNED INCIDENT DEVICE SHOWED NO EVIDENCE OF ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE COMPLAINT WAS NOT CONFIRMED SINCE THE RETURNED UNIT WAS FOUND WITHIN SPECIFICATIONS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND. BASED ON ALL GATHERED INFORMATION, NO FURTHER ACTIONS ARE CONSIDERED NECESSARY. THE MOST PROBABLE ROOT CAUSE IS: NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URETERAL LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING POST PROCEDURE, THE PATIENT COMPLAINED OF PAIN, DISCOMFORT, IRRITATION, AND CONSTANT FEELING OF URINATION IN THE BLADDER AREA WHERE THE POLARIS LOOP WAS IMPLANTED. NO ABNORMITIES WERE NOTED WITH THE PATIENTS ANATOMY PRE PROCEDURE. THE STENT WAS REMOVED IMMEDIATELY IN THE RECOVERY ROOM OF THE HOSPITAL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS LOOP URETERAL STENT WAS USED DURING A URETERAL LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING POST PROCEDURE, THE PATIENT COMPLAINED OF PAIN, DISCOMFORT, IRRITATION, AND CONSTANT FEELING OF URINATION IN THE BLADDER AREA WHERE THE POLARIS LOOP WAS IMPLANTED. NO ABNORMITIES WERE NOTED WITH THE PATIENTS ANATOMY PRE PROCEDURE. THE STENT WAS REMOVED IMMEDIATELY IN THE RECOVERY ROOM OF THE HOSPITAL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282829 POLARIS? LOOP STENT, URETERAL FAD BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0061552220 0015635932

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other