BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUNWAY 6 FRENCH FR-4 GUIDE CATHETER

    MDR report key: 540045 · Received August 19, 2004

    Report

    Report Number
    540045
    Event Type
    Injury
    Date Received
    August 19, 2004
    Date of Event
    August 2, 2004
    Report Date
    August 9, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WITH ISCHEMIC HEART DISEASE WAS TAKEN TO CARDIAC CATHETERIZATION LAB FOR DIAGNOSTIC AND THERAPEUTIC CATH. DIAGNOSTIC CATH WAS SUCCESSFULLY PERFORMED. CARDIOLOGIST PLACED A RUNWAY 6 FRENCH FR-4 GUIDE CATHETER AROUND THE AORTIC ARCH. PHYSICIAN REPORTED SOME DIFFICULTY WITH INSERTION OF THE GUIDE CATHETER. THE PHYSICIAN WAS UNABLE TO MANIPULATE THE GUIDE INTO POSITION. IT WOULD NOT TORQUE, AND CARDIOLOGIST WAS UNABLE TO BRING THE GUIDE BACK OUT BECAUSE IT WAS KINKED. VASCULAR SURGEON WAS CONTACTED TO PERFORM EMERGENCY RETRIEVAL/GROIN CUTDOWN TO REMOVE THE CATHETER FROM RIGHT CORONARY ARTERY. PT LEFT THE OPERATING ROOM IN STABLE CONDITION. THE PT RETURNED TO THE CARDIAC CATH LAB 3 DAYS LATER FOR SUCCESSFUL CORONARY ANGIOGRAPHY AND INTRACORONARY DRUG ELUTING STENT OF SINGLE VESSEL. PT DISCHARGED AFTER A 4-DAY HOSPITALIZATION IN GOOD CONDITION TO RETURN TO WORK IN 10 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUNWAY 6 FRENCH FR-4 GUIDE CATHETER GUIDING CARDIAC CATHETER DYB BOSTON SCIENTIFIC CORP. RUNWAY 6 FRENCH FR4 GUIDE CATHETER 6658498

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R