BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADSTIC MICROINTRODUCER KIT

    MDR report key: 1191810 · Received October 1, 2008

    Report

    Report Number
    1191810
    Event Type
    Injury
    Date Received
    October 1, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 29, 2008
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS BROUGHT TO OPERATING ROOM FOR PLACEMENT OF A CENTRAL VENOUS CATHETER WITH FLUOROSCOPIC GUIDANCE BY SURGEON. WHEN REPOSITIONING AND REMOVAL OF THE WIRE WAS ATTEMPTED, RESISTANCE WAS NOTED. THE WIRE BEGAN TO UNRAVEL. AN INTERVENTIONAL RADIOLOGIST WAS UNABLE TO REMOVE THE WIRE WITH CATHETER-BASED THERAPY. SURGEON PERFORMED A LIMITED NECK EXPLORATION AND A CAROTID ANGIOGRAM. THE TIP OF THE WIRE WAS LODGED IN A SMALL BRANCH OF THE EXTERNAL CAROTID ARTERY. AN ARTERIOTOMY WAS PERFORMED AND THE WIRE WAS REMOVED. A 2MM SEGMENT OF THE WIRE REMAINED IN THE BRANCH OF THE EXTERNAL CAROTID ARTERY. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT AFTER THE SURGERY. HE HAS NO NEUROLOGICAL SYMPTOMS AND A FOLLOW-UP ULTRASOUND SHOWED NORMAL BLOOD FLOW IN THE CAROTID ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADSTIC MICROINTRODUCER KIT KIT, CATHETERIZATION DYB BARD ACCESS SYSTEMS * 22C04611

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Other| R