BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIGATORTM HD

    MDR report key: 3231277 · Received July 17, 2013

    Report

    Report Number
    3005099803-2013-06922
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KOD
    PMA / PMN Number
    K122649
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED DURING URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT,AFTER THE ACCESS SHEATH WAS REMOVED, THE PHYSICIAN NOTICED THAT THE URETER WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S URETER WAS SUCCESSFULLY REPAIRED BY THE PHYSICIAN. 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
    332548 NAVIGATORTM HD CATHETER, UROLOGICAL KOD BOSTON SCIENTIFIC - SPENCER M0062502290

    Patients

    Seq Age Sex Outcome Treatment
    1 Other