BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPRESS-WAY RX CATHETER, 6FR

    MDR report key: 6251144 · Received January 13, 2017

    Report

    Report Number
    3011175548-2017-00003
    Event Type
    Injury
    Date Received
    January 13, 2017
    Date of Event
    January 2, 2017
    Report Date
    January 9, 2017
    Manufacturer
    KANEKA PHARMA AMERICA LLC
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING AN ASPIRATION OF A CLOT IN THE RIGHT CORONARY ARTERY (RCA). SEVERAL ASPIRATIONS WERE MADE AND WHEN THE XPRESSWAY CATHETER WAS BEING REMOVED IT WOULD NOT COME OUT OF THE DELIVERY CATHETER. HE HAD TO PULL EVERYTHING OUT AND GO TO THE OTHER GROIN. UPON REMOVAL TIP WAS NOTED TO BROKEN.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING AN ASPIRATION OF A CLOT IN THE RIGHT CORONARY ARTERY (RCA). SEVERAL ASPIRATIONS WERE MADE AND WHEN THE XPRESSWAY CATHETER WAS BEING REMOVED IT WOULD NOT COME OUT OF THE DELIVERY CATHETER. HE HAD TO PULL EVERYTHING OUT AND GO TO THE OTHER GROIN. UPON REMOVAL TIP WAS NOTED TO BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32041 XPRESS-WAY RX CATHETER, 6FR CATHETER, EMBOLECTOMY DXE KANEKA PHARMA AMERICA LLC T2R6SA4A KP046628

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention