BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WORLEY-STD

    MDR report key: 1151570 · Received September 3, 2008

    Report

    Report Number
    1151570
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 3, 2008
    Manufacturer
    THOMAS MEDICAL PRODUCTS, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING AN ICD LEAD CHANGED IN THE CARDIAC CATH LAB. INTRODUCER USED AND AT ONE POINT THE TIP OF THE INTRODUCER SHEAR OFF AS IT WAS BEING REMOVED. CT CONFIRMED THE PRESENCE OF A 7MM RADIOPAQUE FOREIGN BODY IN THE RIGHT HEPATIC VEIN. FOREIGN BODY NOT REMOVED. PATIENT ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WORLEY-STD CORONARY SINUS GUIDE DYB THOMAS MEDICAL PRODUCTS, INC. CSG/WORLEY/B-1-09 S14590

    Patients

    Seq Age Sex Outcome Treatment
    1 Other