BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATOR?

    MDR report key: 2784008 · Received October 11, 2012

    Report

    Report Number
    3005099803-2012-04703
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KOD
    PMA / PMN Number
    K022135
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF DEVICE CATHETER FLAKED.

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED PRODUCT CONFIRMED THAT COATING ON THE SHEATH WAS PEELING. THE INVESTIGATION PERFORMED BY TELEFLEX MEDICAL CONFIRMED THE CUSTOMER COMPLAINT THAT THE COATING WAS PEELING OFF THE SHEATH. HOWEVER, BASED ON THE INVESTIGATION, THE ROOT CAUSE IS UNDETERMINABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR URETERAL CATHETER WAS DISCOVERED IN THE HOSPITAL'S INVENTORY WHERE THEY COULD SEE THE PLASTIC PEELING OFF OF THE SHEATH THROUGH THE CLEAR UNOPENED PACKAGING. THE DEVICE WAS NOT USED IN ANY PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR URETERAL CATHETER WAS DISCOVERED IN THE HOSPITAL'S INVENTORY WHERE THEY COULD SEE THE PLASTIC PEELING OFF OF THE SHEATH THROUGH THE CLEAR UNOPENED PACKAGING. THE DEVICE WAS NOT USED IN ANY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVIGATOR? CATHETER, UROLOGICAL KOD BOSTON SCIENTIFIC - SPENCER M0062502040 2402370301

    Patients

    Seq Age Sex Outcome Treatment
    1