BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6G MARCH I GUIDE CATHETER

    MDR report key: 618820 · Received June 29, 2005

    Report

    Report Number
    6000093-2005-00774
    Event Type
    Injury
    Date Received
    June 29, 2005
    Date of Event
    June 2, 2005
    Report Date
    June 2, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PTA TREATMENT PROCEDURE, THE TIP OF THE 6F MACH I GUIDE CATHETER BECAME SEPARATED FROM THE CATHETER SHAFT. THE GUIDE CATHETER WAS ADVANCED INTO THE RIGHT RENAL ARTERY. A 0.18 THRUWAY GUIDEWIRE WAS ADVANCED TO THE DISTAL TIP OF THE GUIDE CATHETER WHEN RESISTANCE WAS ENCOUNTERED. THE GUIDEWIRE WAS PULLED BACK APPROXIMATELY 3 CM AND ADVANCED, AGAIN ENCOUNTERING RESISTANCE. THE GUIDEWIRE WAS PULLED BACK A SECOND TIME AND THE DISTAL TIP OF THE GUIDE CATHETER BECAME SEPARATED FROM THE SHAFT. THE CATHETER TIP BECAME LODGED IN THE MESENTERIC ARTERY. ATTEMPTS TO RETRIEVE THE TIP WERE UNSUCCESSFUL. THE PROCEDURE WAS STOPPED. THE PATIENT WAS MONITORED AND REMAINED STABLE FOR 48 HOURS FOLLOWING THE PROCEDURE. A RENAL PROCEDURE WAS SUCCESSFULLY COMPLETED FOUR DAYS AFTER THE INITIAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6G MARCH I GUIDE CATHETER GUIDING CATHETER DQX BOSTON SCIENTIFIC NA 6935570

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R