BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS URETERAL STENT

    MDR report key: 10304831 · Received July 21, 2020

    Report

    Report Number
    3005099803-2020-02859
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    January 1, 2019
    Report Date
    August 21, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE REPORTED EVENT DATE OF 2019. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: CONCLUSION CODE 4316 IS BEING USED IN LIEU OF AN ADEQUATE CONCLUSION CODE FOR DEVICE NOT RETURNED. BLOCK H6: DEVICE CODE 243 CAPTURES THE REPORTABLE EVENT OF STENT OCCLUDED. DEVICE CODE 1528 CAPTURES THE REPORTABLE EVENT OF STENT DIFFICULT TO REMOVE. PATIENT CODE 1858 CAPTURES THE REPORTABLE EVENT OF FEVER. PATIENT CODE 1930 CAPTURES THE REPORTABLE EVENT OF INFECTION. BLOCK H10: THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ADDITIONAL INFORMATION, BLOCK A1, A2, B3, B5, E1.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A PERCUTANEOUS LEFT URETERAL LITHOTRIPSY, URETERAL STENT PLACEMENT PROCEDURE IN THE URETER. THE EXACT EVENT DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS DIAGNOSED WITH LEFT URETERAL STONE AND LEFT HYDRONEPHROSIS, NOT RELATED TO A BOSTON SCIENTIFIC DEVICE. A MONTH LATER, A PNL PROCEDURE WAS PERFORMED. FIVE DAYS AFTER PROCEDURE, NEPHROSTOMY EXAMINATION WAS PERFORMED. IT WAS CONFIRMED THAT THERE WAS NO CONTRAST MEDIA LEAKING IN PUJ. THE NEXT DAY, A STRICTURE OF THE URETER WAS OBSERVED DUE TO URETERAL EDEMA WAS SUSPECTED, A RP (RETROGRADE PYELOGRAM) AND POLARIS ULTRA URETERAL STENT PLACEMENT WAS PERFORMED. A CONTRAST MEDIA WAS ABLE TO FLOW EVEN THOUGH THERE WAS PUJ STENOSIS. THE NEXT DAY, NON-BOSTON SCIENTIFIC NEPHROSTOMY CLAMPING WAS PERFORMED. THE FOLLOWING DAY, THE PATIENT HAD A FEVER OF 39C, AND THE NON-BOSTON SCIENTIFIC NEPHROSTOMY CLAMP WAS REMOVED. TWO WEEKS AFTER, A NEPHROSTOMY EXAMINATION WAS PERFORMED, CONTRAST MEDIA FLOWED BETWEEN URETER AND BLADDER, A NEPHROSTOMY CLAMPING WAS PERFORMED. THE FOLLOWING DAY, THE NON-BOSTON SCIENTIFIC NEPHROSTOMY CLAMP WAS REMOVED. AFTER ABOUT 3 WEEKS, THE PATIENT WAS HOSPITALIZED URGENTLY DUE TO PYELONEPHRITIS. THE NEXT DAY, LEFT HYDRONEPHROSIS WAS FOUND UPON CT, THE POLARIS ULTRA URETERAL STENT WAS REPLACED WITH AN UNKNOWN STENT. THE PROCEDURE WAS DIFFICULT DUE TO HIGH NECK, AND THE POLARIS ULTRA URETERAL STENT ON THE RENAL PELVIC SIDE WAS OCCLUDED. PROGRESS AFTER THE PROCEDURE WAS GOOD, AND THE PATIENT WAS DISCHARGED AFTER 6 DAYS OF HOSPITALIZATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS DISCARDED BY THE FACILITY. ***ADDITIONAL INFORMATION RECEIVED ON 10AUG2020*** A MONTH LATER, IN (B)(6) 2018 A PNL PROCEDURE WAS PERFORMED. THE NEXT DAY, IN (B)(6) 2018, A STRICTURE OF THE URETER WAS OBSERVED DUE TO URETERAL EDEMA WAS SUSPECTED, A RP (RETROGRADE PYELOGRAM) AND POLARIS ULTRA URETERAL STENT PLACEMENT WAS PERFORMED. AFTER ABOUT 3 WEEKS, THE PATIENT WAS HOSPITALIZED URGENTLY DUE TO PYELONEPHRITIS. THE NEXT DAY IN 2019, LEFT HYDRONEPHROSIS WAS FOUND UPON CT, THE POLARIS ULTRA URETERAL STENT WAS REPLACED WITH AN UNKNOWN STENT. THE PROCEDURE WAS DIFFICULT DUE TO HIGH NECK, AND THE POLARIS ULTRA URETERAL STENT ON THE RENAL PELVIC SIDE WAS OCCLUDED. PROGRESS AFTER THE PROCEDURE WAS GOOD, AND THE PATIENT WAS DISCHARGED AFTER 6 DAYS OF HOSPITALIZATION.

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA URETERAL STENT WAS USED DURING A PERCUTANEOUS LEFT URETERAL LITHOTRIPSY, URETERAL STENT PLACEMENT PROCEDURE IN THE URETER. THE EXACT EVENT DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS DIAGNOSED WITH LEFT URETERAL STONE AND LEFT HYDRONEPHROSIS, NOT RELATED TO A BOSTON SCIENTIFIC DEVICE. A MONTH LATER, A PNL PROCEDURE WAS PERFORMED. FIVE DAYS AFTER THE PROCEDURE, A NEPHROSTOMY EXAMINATION WAS PERFORMED. IT WAS CONFIRMED THAT THERE WAS NO CONTRAST MEDIA LEAKING IN PELVIC-URETERIC JUNCTION, PUJ. THE NEXT DAY, A STRICTURE OF THE URETER WAS OBSERVED DUE TO SUSPECTED URETERAL EDEMA, A RP (RETROGRADE PYELOGRAM) AND POLARIS ULTRA URETERAL STENT PLACEMENT WAS PERFORMED. A CONTRAST MEDIA WAS ABLE TO FLOW EVEN THOUGH THERE WAS PUJ STENOSIS. THE NEXT DAY, NON-BOSTON SCIENTIFIC NEPHROSTOMY CLAMPING WAS PERFORMED. THE FOLLOWING DAY, THE PATIENT HAD A FEVER OF 39C, AND THE NON-BOSTON SCIENTIFIC NEPHROSTOMY CLAMP WAS REMOVED. AFTER ABOUT 3 WEEKS, THE PATIENT WAS HOSPITALIZED URGENTLY DUE TO PYELONEPHRITIS. THE NEXT DAY, LEFT HYDRONEPHROSIS WAS FOUND UPON CT, THE POLARIS ULTRA URETERAL STENT WAS REPLACED WITH AN UNKNOWN STENT. THE STENT REMOVAL PROCEDURE WAS DIFFICULT DUE TO HIGH NECK, AND THE POLARIS ULTRA URETERAL STENT ON THE RENAL PELVIC SIDE WAS OCCLUDED. PROGRESS AFTER THE PROCEDURE WAS GOOD, AND THE PATIENT WAS DISCHARGED AFTER 6 DAYS OF HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765623 POLARIS URETERAL STENT STENT, URETERAL FAD BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R