BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDI-TECH

    MDR report key: 41604 · Received October 1, 1996

    Report

    Report Number
    41604
    Event Type
    Injury
    Date Received
    October 1, 1996
    Date of Event
    September 19, 1996
    Report Date
    September 23, 1996
    Manufacturer
    MEDI-TECH, INC.
    Product Code
    LIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AORTOGRAM AND LOWER EXTREMITY ARTERIOGRAM PERFORMED VIA LEFT AXILLARY ARTERY. ATTEMPTED BALLOON DILATION IMMEDIATELY FOLLOWED VIA LEFT AXILLARY ARTERY, BUT BALLOON CATHETER BROKE IN THE INFRARENAL AORTA. PT IS QUESTIONABLE SURGICAL CANDIDATE, HAD EARLIER DECLINED SURGERY FOR BYPASS GRAFT. THEREFORE, THE DISTAL CATHETER FRAGMENT, ABOUT 10 CM LONG, REMAINS IN HER DISTAL AORTA. POSSIBLE FUTURE OCCLUSION OF AORTIC BIFURCATION WITH BYPASS GRAFT FOLLOWING UNSUCCESSFUL ATTEMPT TO ANGIOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-TECH BALLOON DILATATION CATHETER LIT MEDI-TECH, INC. DC/10-3/8/100 119301

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR