BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE SENSOR

    MDR report key: 478565 · Received August 14, 2003

    Report

    Report Number
    8030904-2003-00007
    Event Type
    Injury
    Date Received
    August 14, 2003
    Date of Event
    July 14, 2003
    Report Date
    August 13, 2003
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    "THE DEVICE WAS INITIALLY USED TO EVALUATE A LAD LESION THROUGH A 6FR DIAGNOSTIC CATHETER. DR. DECIDED TO MOVE ONTO AN INTERVENTION. AT THIS POINT THEY ALSO DECIDED THEY WANTED TO SIZE UP TO A 7FR SYSTEM AND CHOSE TO DO THIS OVER THE .014 GUIDEWIRE. WHEN THEY TRIED TO INSERT THE 7FR SHEATH OVER THE WIRE IT BROKE AT THIS JUNCTION. THEY THEN LOST ACCESS AT THE RIGHT GROIN SITE. THE DISTAL WIRE WAS STILL IN LAD. THEY ACCESSED THE LEFT GROIN AND SNARED THE WIRE THAT WAS IN THE ABDOMINAL AORTA. IT TOOK QUITE A WHILE TO DO THIS. THE WIRE THEN BROKE AGAIN AND THEY ENSNARED IT AND REMOVED IT FROM THE LAD. PT. REMAINED STABLE. THE ENTIRE PROCESS TOOK APPROX 4-5 HRS. PT. WENT TO SURGERY TO REPAIR RIGHT GROIN AND TO REMOVE THE OTHER TWO PIECES OF THE WIRE. PT. CAME THROUGH SURGERY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSUREWIRE SENSOR GUIDEWIRE SENSOR DQX RADI MEDICAL SYSTEMS AB 12304 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention 7FR SHEATH