BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS? ULTRA

    MDR report key: 3192362 · Received June 27, 2013

    Report

    Report Number
    3005099803-2013-05775
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FAD
    PMA / PMN Number
    K030503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 STENT DEPLOYMENT PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, AFTER UNPACKING, THE PHYSICIAN ATTEMPTED TO ADVANCE A POLARIS ULTRA STENT BUT THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE STENT BECAUSE HE FOUND A CRACK ON THE PIGTAIL OF BLADDER SIDE WHILE THE STENT WAS ADVANCED ON THE GUIDEWIRE THROUGH THE SCOPE TOWARDS THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT COMPANY'S SAMPLE DEVICE. THERE WERE NO 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
    293997 POLARIS? ULTRA STENT, URETERAL FAD BOSTON SCIENTIFIC - COSTA RICA (COYOL) M006192152090 16049957

    Patients

    Seq Age Sex Outcome Treatment
    1