BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILOOKO25 PERSONAL IMAGING TOOL

    MDR report key: 3057411 · Received April 26, 2006

    Report

    Report Number
    3032367-2005-00002
    Event Type
    Injury
    Date Received
    April 26, 2006
    Date of Event
    March 29, 2006
    Report Date
    April 26, 2006
    Manufacturer
    SONOSITE,INC.
    Product Code
    IYN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPEATED ATTEMPTS TO CONTACT THE DOCTOR INVOLVED IN THIS INCIDENT HAVE BEEN MADE, HOWEVER WE HAVE BEEN UNSUCCESSFUL IN OBTAINING ANY ADDITIONAL INFORMATION. AT THIS TIME, WE HAVE NO EVIDENCE TO SUGGEST THAT A PRODUCT MALFUNCTIONED OCCURRED.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT THEY WERE USING THE ILOOK PERSONAL IMAGING TOOL FOR TRANSVERSE IMAGING OF THE INTERNAL JUGULAR AT THE MID-NECK LEVEL, AND HAD A DIFFICULT TIME SEEING THE NEEDLE OR TISSUE COMPRESSION AS THE NEEDLE ADVANCED. THE DOCTOR REPORTED THAT HE ENDED UP STICKING THE CAROTID ARTERY BUT STILL COULD NOT VISUALIZE THE NEEDLE TIP EITHER IN THE CAROTID OR INTERNAL JUGULAR. THE NEEDLE WAS THEN REMOVED. WHEN THE DOCTOR TRIED TO IMAGE THE INTERNAL JUGULAR AGAIN, HE COULDN'T FIND IT AND SURMISED THAT A HEMATOMA FROM THE CAROTID PUNCTURE HAD COMPRESSED AND COLLAPSED THE INTERNAL JUGULAR. THE PATIENT DEVELOPED A SMALL APICAL PNEUMOTHORAX ON THEIR CHEST X-RAY AND A FOLLOW-UP FILM SHOWED AN ENLARGEMENT LATER IN THE DAY. A CHEST TUBE WAS PLACED AND THE HEMOTHORAX WAS DRAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILOOKO25 PERSONAL IMAGING TOOL ULTRASOUND SYSTEM IYN SONOSITE,INC. P02976 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention