BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUNWAY GUIDE CATHETER

    MDR report key: 1220091 · Received October 31, 2008

    Report

    Report Number
    2134265-2008-04166
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Report Date
    October 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K033441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE GUIDE CATHETER WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE GUIDE CATHETER COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE, THE TIP OF THE RUNWAY GUIDE CATHETER SEEMED TO BE "BROKEN OR DAMAGED." THE DEVICE HAD NO CONTACT WITH THE PT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUNWAY GUIDE CATHETER DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC NA 11926211

    Patients

    Seq Age Sex Outcome Treatment
    1