BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROFINITY HYDROPHILLIC GUIDE WIRE

    MDR report key: 3838695 · Received March 12, 2014

    Report

    Report Number
    3007635982-2014-00002
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 7, 2014
    Manufacturer
    NITINOL DEVICES AND COMPONENTS INC
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE EVENT DESCRIPTION IN THE COMPLAINT DOCUMENTATION PROVIDED TO NITINOL DEVICES AND COMPONENTS READS AS FOLLOWS. "ADVANCED WIRE THROUGH SHEATH. PLACED SEEKER OVER WIRE. ATTEMPTED TO CROSS AT CTO. LOOPED WIRE, PUSHED INTO AT, SEEKER FOLLOWED. WHEN PHYSICIAN PULLED BACK WIRE THE TIP BROKE OFF. PHYSICIAN FELT SOME RESISTANCE BUT HE DIDN'T FEEL IT ANY MORE RESISTANCE THAN HE HAS FELT DURING OTHER CASES." ADDITIONAL INFORMATION PROVIDED IN SUBSEQUENT EMAIL INDICATED THE FOLLOWING. THE GUIDE WIRE TIP WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE PATIENT'S CONDITION IS STABLE. ROUTINE FOLLOW-UP BY PHYSICIAN IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148369 HYDROFINITY HYDROPHILLIC GUIDE WIRE WIRE, GUIDE, CATHETER DQX NITINOL DEVICES AND COMPONENTS INC 82116555

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention