BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4F V-STICK¿ VASCULAR ACCESS SET WITH GUIDEWIRE

    MDR report key: 7022183 · Received November 10, 2017

    Report

    Report Number
    1625425-2017-00152
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    October 10, 2017
    Report Date
    November 10, 2017
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DYB
    PMA / PMN Number
    K011790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS AND INSPECTION RECORDS WAS CONDUCTED, AND NO SIMILAR CONCERNS WERE FOUND. THE GUIDEWIRE INCLUDED IN THE V-STICK¿ VASCULAR ACCESS SET IS THE COMPONENT THAT WAS RETURNED AND EVALUATED. THE COIL OF THE WIRE WAS STRETCHED. THE TIP OF THE WIRE WAS STILL INTACT (CORE WELDED TO COIL), ALTHOUGH THE CORE HAD BROKEN A FEW MILLIMETERS FROM THE END. THE SOLDER OF THE COIL TO THE CORE WAS ALSO STILL INTACT. SCRATCHES WERE NOTED ALONG THE PROXIMAL END OF THE WIRE. THE WIRE EXHIBITED SOME BENDING NEAR THE AREA WHERE THE CORE SEPARATED. THE WELD AT THE TIP OF THE WIRE WAS CORRECT, AS WAS THE SOLDER OF THE WIRE TO THE COIL. POTENTIAL CAUSES FOR THIS COMPLAINT INCLUDE MISHANDLING IN THE FIELD (FOR INSTANCE, IF THE GUIDEWIRE BECAME KINKED OR STUCK, THE USER MAY HAVE APPLIED EXCESS PULLING FORCE, OR THE USER MAY HAVE WITHDRAWN THE GUIDEWIRE THROUGH THE NEEDLE). THE DIRECTIONS FOR USE INCLUDED WITH THIS KIT STATE "THE GUIDEWIRE SHOULD NOT BE WITHDRAWN THROUGH THE NEEDLE. DAMAGE OR SHEARING OF THE GUIDEWIRE MAY OCCUR."

    Description of Event or Problem · 1

    NITINOL WIRE UNWOUND WHEN BEING REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802447 4F V-STICK¿ VASCULAR ACCESS SET WITH GUIDEWIRE VASCULAR ACCESS SET WITH GUIDEWIRE DYB ARGON MEDICAL DEVICES INC. 11189216

    Patients

    Seq Age Sex Outcome Treatment
    1 Other