BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIEMENS MEDICAL SYSTEMS, INC.

    MDR report key: 53748 · Received December 3, 1996

    Report

    Report Number
    53748
    Event Type
    Death
    Date Received
    December 3, 1996
    Date of Event
    November 26, 1996
    Report Date
    December 2, 1996
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC.
    Product Code
    IZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT SCHEDULED FOR RIGHT AND LEFT HEART CATHETERIZATION. DURING ANGIOGRAPHY, SLOW FLOW WAS NOTED IN THE LAD WITH THE CATHETER WEDGED INTO THE PROXIMAL LAD. PT IMMEDIATELY SET UP FOR PTCA WITH STENT PLACEMENT. INTRA-AORTIC BALLOON PUMP INSERTED WHILE PT WAS STABLE. ANGIOPLASTY TO LAD ATTEMPTED. A HIGH TORQUE FLOPPY WIRE WOULD NOT CROSS THE LESION, THEN A SILK WIRE CROSSED, BUT PHYSICIAN COULD NOT DEPLOY STENT. DURING ATTEMPT, GUIDE WIRE CAME OUT OF THE LAD. PT THEN INTUBATED. AT THIS POINT, X-RAY FLUOROSCOPY MALFUNCTIONED AND PHYSICIAN WAS WITHOUT X-RAY GUIDANCE. FLUOROSCOPY NEVER CAME BACK. SVC REP WAS CALLED FOR GUIDANCE ON TROUBLESHOOTING, BUT PT WAS PRONOUNCED AT 10:24 AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS MEDICAL SYSTEMS, INC. BICOR FLUOROSCOPY IZO SIEMENS MEDICAL SYSTEMS, INC. 8338063X1512 *
    2 SIEMENS MEDICAL SYSTEMS, INC. BICOR FLUOROSCOPY IZO SIEMENS MEDICAL SYSTEMS, INC. 9023136G096E *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death