BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIGATORTM HD

    MDR report key: 3142734 · Received June 3, 2013

    Report

    Report Number
    3005099803-2013-04364
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KOD
    PMA / PMN Number
    K122649
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. 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 NAVIGATOR URETERAL ACCESS SHEATH WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THEY NOTICED A TEAR IN THE URETER AFTER PLACEMENT OF THE DEVICE. THEY WERE ABLE TO REMOVE THE STONE AND PLACED THE STENT. THE PROCEDURE WAS COMPLETED WITH THIS 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 FINE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244457 NAVIGATORTM HD CATHETER, UROLOGICAL KOD BOSTON SCIENTIFIC - SPENCER M0062502250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention