BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS? ULTRA

    MDR report key: 3853689 · Received June 6, 2014

    Report

    Report Number
    3005099803-2014-02145
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FAD
    PMA / PMN Number
    K010002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (B)(4). 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 ASSESSMENT OF THE RETURNED POLARIS ULTRA URETERAL STENT WAS PERFORMED AND A KINK AT 2.3CM FROM THE RENAL PIGTAIL WAS FOUND. IN ADDITION, RESIDUES WERE NOTED ON THE STENT AND THE SUTURE WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED IN THE COMPLAINT. A LABELING REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND.  THEREFORE, BASED ON THE AVAILABLE INFORMATION AND THE DEVICE'S CONDITION, THE MOST PROBABLE ROOT CAUSE IS "OPERATIONAL CONTEXT", SINCE IT IS MOST LIKELY THAT DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT DEVICE WAS IMPLANTED IN THE URINARY DUCT OF THE PATIENT ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, A FEW HOURS POST-PROCEDURE, IT WAS NOTICED THAT THE DRAINAGE DID NOT WORK PROPERLY, SO A STENT REPLACEMENT PROCEDURE WAS PERFORMED. HOWEVER, WHEN THE STENT WAS REMOVED, THE PART OF THE STENT IN THE URETEROPELVIC JUNCTION WAS FOUND TO BE KINKED. ANOTHER POLARIS ULTRA STENT WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN REPORTED THAT THE PATIENT WAS SMALL AND THE LENGTH OF THE STENT MAY HAVE BEEN TOO LONG AND THINKS THAT IT WAS PROCEDURAL ISSUE. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT DEVICE WAS IMPLANTED IN THE URINARY DUCT OF THE PATIENT ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, A FEW HOURS POST-PROCEDURE, IT WAS NOTICED THAT THE DRAINAGE DID NOT WORK PROPERLY, SO A STENT REPLACEMENT PROCEDURE WAS PERFORMED. HOWEVER, WHEN THE STENT WAS REMOVED, THE PART OF THE STENT IN THE URETEROPELVIC JUNCTION WAS FOUND TO BE KINKED. ANOTHER POLARIS ULTRA STENT WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN REPORTED THAT THE PATIENT WAS SMALL AND THE LENGTH OF THE STENT MAY HAVE BEEN TOO LONG AND THINKS THAT IT WAS PROCEDURAL ISSUE. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333123 POLARIS? ULTRA STENT, URETERAL FAD BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0061931320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention