BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 343599 · Received July 24, 2001

    Report

    Report Number
    343599
    Event Type
    Other
    Date Received
    July 24, 2001
    Date of Event
    December 12, 2000
    Report Date
    July 18, 2001
    Manufacturer
    SIEMENS MEDICAL
    Product Code
    IZI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD AN ANGIOCARDIOGRAM IN CATH LAB ROOM WHICH INDICATED A 90-95% NARROWING OF THE RIGHT CORONARY ARTERY. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS THEN PERFORMED IN THE SAME X-RAY ROOM. THE TOTAL FLUOROSCOPY TIME WAS 115 MINUTES AND 2439 DIGITAL CINE FRAMES WERE OBTAINED. THE PT HAD A PREVIOUS ANGIOCARDIOGRAM IN 2000, IN WHICH THE TOTAL FLUOROSCOPY TIME WAS 5.2 MINUTES AND 1389 DIGITAL CINE FRAMES WERE OBTAINED. IN 2001 THE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) AND PLACEMENT OF AN INTRACORONARY STENT WERE PERFORMED. THE TOTAL FLUOROSCOPY TIME WAS 36 MINUTES AND 811 DIGITAL CINE FRAMES WERE OBTAINED. THE CONSULTATION NOTE OF JUNE 27, 2001 STATES "LESION OVER RIGHT SCAPULAR AREA WITH DEEP ULCERATION AND SURROUNDING ERYTHEMA AND INDURATION." THE PRESENCE OF THE LESION WAS COMMUNICATED TO CLINICAL MGR, CARDIOLOGY INVASIVE SERVICES ON JULY 2, 2001. PAST MEDICAL HISTORY: MYOCARDIAL INFARCTION TIMES 3, DIABETES TYPE 2, HYPERTENSION, AND INCREASED CHOLESTEROL. THE ENTRANCE TABLETOP EXPOSURE RATE DURING FLUOROSCOPY WAS MEASURED TO BE 4.8 R/MIN FOR THE FOLLOWING CONDITIONS: 106 KVP, 8.4 MA, 15 FRAMES PER SECOND, 17 CM FIELD OF VIEW, 87 CM SOURCE TO IMAGE RECEPTOR DISTANCE, AND 51 CM SOURCE TO SKIN DISTANCE. FOR DIGITAL CINE MODE (15 FPS) THE ENTRANCE TABLETOP EXPOSURE RATE WAS MEASURED TO BE 70 R/MIN. THE ESTIMATED EXPOSURE FOR THE PROCEDURE CONDUCTED ON MAY 8, 2000 IS 130 TO 190 R. THE ESTIMATED EXPOSURE FOR THE PROCEDURES CONDUCTED ON DECEMBER 12, 2000 IS 750 TO 1050 R. THE ESTIMATED EXPOSURE FOR THE PROCEDURE CONDUCTED ON MARCH 1, 2001 IS 230 TO 330 R. AUTOMATIC BRIGHTNESS CONTROL COMPENSATES FOR LARGE PT SIZE BY INCREASING FLUOROSCOPY OUTPUT. LARGE PT SIZE INHIBITED C-ARM PLACEMENT (PROJECTIONS), WHICH COULD PROVIDE ASSESSMENT OF VESSELS. IMAGE QUALITY WAS SUBOPTIMAL DUE TO PT SIZE, THEREBY LENGTHENING THE FLUOROSCOPY TIME FOR CLINICAL ASSESSMENT OF THE PT. THE UNIT WAS EVALUATED, INCLUDING EXPOSURE RATE, ON MAY 3, 2000 AND JULY 5, 2001 BY A MEDICAL PHYSICIST (REPORTS DATED MAY 8, 2000 AND JULY 11, 2001). CLINICAL ENGINEERING MEASURED MAXIMUM TABLETOP EXPOSURE RATE ON OCTOBER 24, 2000, FEBRUARY 17, 2001, APRIL 13, 2001, AND JUNE 6, 2001. THESE MEASUREMENTS DEMONSTRATED THAT MAXIMUM EXPOSURE RATES WERE WITHIN REGULATORY LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33346 * C-ARM IZI SIEMENS MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other