BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8 FR VISTA BRITE TIP GUIDE CATH

    MDR report key: 509862 · Received February 3, 2004

    Report

    Report Number
    509862
    Event Type
    Malfunction
    Date Received
    February 3, 2004
    Date of Event
    December 31, 2003
    Report Date
    January 22, 2004
    Manufacturer
    CORDIS/J & J
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GUIDE CATHETER FRACTURED MID-SHAFT (APPROX. 15" FROM HUB) DURING MANIPILATION OF THE CATHETER TO CANNULATE THE CORONARY OSTIUM. HUB OF THE CATHETER WAS REMOVED FROM THE PUNCTURE SITE IN THE CATH LAB. REMAINDER OF CATHETER WAS LODGED IN RIGHT ILIAC ARTERY REQUIRING SURGICAL REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8 FR VISTA BRITE TIP GUIDE CATH GUIDE CATHETER DYB CORDIS/J & J 588-831 X1103459

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR CARDIAC CATH (INTERVENT. #1), 2003.| CARDIAC CATH (INTERVENT. #2), 2003.