BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SV-5 WIRE

    MDR report key: 3937386 · Received July 9, 2014

    Report

    Report Number
    3937386
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 3, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ONCE ACCESS WAS MADE INTO THE RIGHT FEMORAL ARTERY AN ANGIOGRAPHY CATHETER WAS INSERTED AND THE CORDIS SV-5 GUIDE WIRE WAS INSERTED. THE INTERVENTIONALIST WAS MANIPULATING THE WIRE UP THROUGH THE FEMORAL ARTERY TOWARD THE RIGHT AXILLARY ARTERY THAT WAS NOTED TO HAVE A TOTAL OCCLUSION. (THE PATIENT'S PSH INCLUDED A PRIOR STENT PLACED IN THE RIGHT AXILLARY ARTERY.) THE MD NOTICED ON FLOURO THAT ONE OF THE THREADS OF THE GUIDE WIRE HAD UNRAVELED. THE WIRE WAS REMOVED INTACT WITHOUT INCIDENCE. THE WIRE WAS PLACED IN A BIOHAZARD BAG AND RETAINED BY THE DEPARTMENT DIRECTOR. THE MANUFACTURER'S REP WAS CALLED AND MADE AWARE OF THE INCIDENT. THE WIRE WILL BE RETURNED TO THE REP.======================MANUFACTURER RESPONSE FOR INTERVENTIONAL GUIDE WIRE, SV-5 WIRE (PER SITE REPORTER).======================MANUFACTURER'S REP, JAMIE KAUFFMAN, 954-654-0707, WAS CONTACTED BY CCL AND MADE AWARE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399064 SV-5 WIRE GUIDEWIRE, CATHETER, STEERABLE NDQ CORDIS CORPORATION 503-558X 35220722

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR WIRES, BALLOONS AND STENTS.| OTHER| PATIENT AT THE TIME OF THE EVENT, THIS INCLUDED| THERE WERE MULTIPLE DEVICES BEING USED ON THE