BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART CATH LAB

    MDR report key: 440283 · Received January 28, 2003

    Report

    Report Number
    MW1027378
    Event Type
    Injury
    Date Received
    January 28, 2003
    Date of Event
    December 20, 2002
    Manufacturer
    G.E. MEDICAL SYSTEMS
    Product Code
    JAA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN OCTOBER 2002 THE PATIENT HAD AN ATRIAL FIBRILLATION RADIOFREQUENCY CATHETER ABLATION IN CATH LAB (GENERAL ELECTRIC ADVANTX). THE TOTAL FLUOROSCOPY TIME WAS 193 MINUTES. THE TECHNIQUE FACTORS WERE 120 KVP AND 5.0 MA FOR A 9-INCH FIELD OF VIEW. PULSED FLUOROSCOPY IS NOT AVAILABLE IN THIS ROOM. ON EVENT DATE, THE DERMATOLOGIST, COMMUNICATED TO THE MEDICAL PHYSICIST THAT THE PATIENT HAD PRESENTED WITH ERYTHEMA 5-6 WEEKS POST PROCEDURE, OVAL IN SHAPE, AND ON THE PATIENT'S BACK, RIGHT SIDE. MOIST DESQUAMATION HAD OCCURRED FOR SOME SMALL LESIONS. THE PRESENCE OF THE SKIN INJURY WAS COMMUNICATED TO CLINICAL MANAGER. THE MEDICAL PHYSICIST INTERVIEWED THE DR. REGARDING THE PROCEDURE PERFORMED IN OCTOBER 2002. DR. STATED THAT THE LAO PROJECTION WAS USED APPROXIMATELY 50% OF THE FLUOROSCOPY BEAM-ON TIME. THE CASE WAS MOVED FROM ROOM TO ROOM BECAUSE POOR IMAGE QUALITY IN FIRST ROOM WAS INADEQUATE TO PERFORM THE PROCEDURE. THE MEDICAL PHYSICIST TALKED WITH THE PATIENT BY TELEPHONE PER THE PATIENT'S REQUEST. THE TOTAL SKIN DOSE AT THE SITE OF THE LESION WAS PROVIDED TO THE PATIENT. CONTINUED FOLLOW-UP FOR THE NEXT FEW MONTHS BY THE PATIENT'S DERMATOLOGIST WAS RECOMMENDED. THE ENTRANCE TABLETOP EXPOSURE RATE DURING FLUOROSCOPY WAS DETERMINED TO BE 10 R/MIN OR 0.1 GRAY/MIN. THE ESTIMATED DOSE FOR THE PROCEDURE CONDUCTED IN OCTOBER 2002 IS 1000 TO 1500 RAD (10 TO 15 GRAY), DEPENDING ON THE FRACTION OF TIME FOR THE LAO PROJECTION. AUTOMATIC BRIGHTNESS CONTROL COMPENSATES FOR LARGE PATIENT SIZE BY INCREASING FLUOROSCOPY OUTPUT. IMAGE QUALITY WAS SUBOPTIMAL DUE TO PATIENT SIZE, THEREBY LENGTHENING THE FLUOROSCOPY TIME FOR CLINICAL ASSESSMENT OF THE PATIENT. THE UNIT WAS EVALUATED ON SEPTEMBER 16, 2002 BY A MEDICAL PHYSICIST. THE MAXIMUM EXPOSURE RATE WAS MEASURED TO BE 7.5 R/MIN FOR THE FOLLOWING CONDITIONS: 120 KVP, 4.1 MA, 9-INCH FIELD OF VIEW, 97 CM SOURCE TO IMAGE RECEPTOR DISTANCE, AND 65 CM SOURCE TO SKIN DISTANCE. CLINICAL ENGINEERING MEASURED MAXIMUM TABLETOP EXPOSURE RATE ON SEPTEMBER 6, 2002, OCTOBER 2, 2002, AND DECEMBER 5, 2002. THESE MEASUREMENTS DEMONSTRATED THAT MAXIMUM EXPOSURE RATES WERE WITHIN REGULATORY LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART CATH LAB FLUOROSCOPY JAA G.E. MEDICAL SYSTEMS ADVANTIX SYSTEM *

    Patients

    Seq Age Sex Outcome Treatment
    1 *