BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS¿ ULTRA

    MDR report key: 2841697 · Received November 21, 2012

    Report

    Report Number
    3005099803-2012-05318
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FAD
    PMA / PMN Number
    K030503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF STENT CRACKED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT #3005099803-2012-05317 PERTAINS TO THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A URETEROSCOPY AND POLARIS ULTRA URETERAL STENT PLACEMENT PROCEDURE, THE STENT CRACKED WITHOUT DETACHMENT AT THE PIGTAIL COIL INSIDE THE PATIENT WHEN THE STENT POSITIONER WAS BEING USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER POLARIS ULTRA URETERAL STENT, WITH NO COMPLICATIONS TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS¿ ULTRA STENT, URETERAL FAD BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0061921320 0015338382

    Patients

    Seq Age Sex Outcome Treatment
    1