BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIGATOR ACCESS SHEATH

    MDR report key: 1083433 · Received July 29, 2008

    Report

    Report Number
    3005099803-2008-01312
    Event Type
    Injury
    Date Received
    July 29, 2008
    Report Date
    June 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOD
    PMA / PMN Number
    K030956
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS BEEN RECEIVED BY THIS MANUFACTURER, BUT A PHYSICAL EVAL HAS NOT YET BEEN COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE IF THE DEVICE MET SPECIFICATION. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE CLINICIANS WERE PERFORMING A URETEROSCOPY PROCEDURE ON A PT, BUT DURING THE PROCEDURE (DATE OF EVENT UNK) THE DEVICE TIP BROKE OFF AND THE SHEATH WAS FLAKING. THE COMPLAINANT REPORTED THAT THERE WERE NO PT COMPLICATIONS AS A RESULT OF THE REPORTED PROBLEM. NUMEROUS ATTEMPTS WERE MADE TO OBTAIN ADD'L PT AND EVENT INFO, ALL ATTEMPTS HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVIGATOR ACCESS SHEATH KOD BOSTON SCIENTIFIC CORPORATION M0062502020 2215320701

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention