BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS? ULTRA

    MDR report key: 3270388 · Received August 8, 2013

    Report

    Report Number
    3005099803-2013-07990
    Event Type
    Malfunction
    Date Received
    August 8, 2013
    Date of Event
    July 15, 2013
    Report Date
    July 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FAD
    PMA / PMN Number
    K030503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL ANALYSIS OF THE RETURNED POLARIS ULTRA STENT WAS PERFORMED. THE STENT AND THE POSITIONER WERE RECEIVED WITH ITS ORIGINAL POUCH. FOLLOWING A DETAILED DEVICE ANALYSIS, THE POUCH PRESENTS A HOLE AT THE RIGHT SUPERIOR CORNER AND MARKS OF THE TRAY'S EDGE ON THE WHITE POUCH AREA. THE POUCH IS DAMAGED IN THE INTERNAL PART AT THE CORNERS. THESE ARE EVIDENCES OF MANIPULATION AND PRESSURE APPLIED DURING HANDLING. BASED ON ALL GATHERED INFORMATION, THE MOST PROBABLE ROOT CAUSE IS ¿HANDLING DAMAGE.¿ A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ISSUES WERE IDENTIFIED WHICH MIGHT HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS USED DURING A CYSTOSCOPY WITH STENT CHANGE, RIGHT SIDE PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THEY NOTICED A HOLE IN THE PACKAGING MAKING THE DEVICE UNSTERILE AND COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT 3005099803-2013-08026 PERTAINS TO THE OTHER DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT WAS USED DURING A CYSTOSCOPY WITH STENT CHANGE, RIGHT SIDE PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THEY NOTICED A HOLE IN THE PACKAGING MAKING THE DEVICE UNSTERILE AND COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT 3005099803-2013-08026 PERTAINS TO THE OTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373731 POLARIS? ULTRA STENT, URETERAL FAD BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0061921320 0015950985

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR