BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORONARY DILATION CATHETER

    MDR report key: 35107 · Received July 24, 1996

    Report

    Report Number
    35107
    Event Type
    Injury
    Date Received
    July 24, 1996
    Date of Event
    March 6, 1996
    Report Date
    March 22, 1996
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: ROTATIONAL ATHERECTOMY. PROBLEM: WITHDRAWAL OF THE BALLOON WAS QUITE DIFFICULT. AT THE TIME OF WITHDRAWAL THE DISTAL HALF OF THE BALLOON WAS NOT ON THE BALLOON SHAFT. ACTION: PT TAKEN BACK TO CATHETERIZATION LAB NEXT MORNING. ANGIOSCOPY AND ULTRASOUND WAS UNSUCCESSFUL IN VISUALIZING ANY BALLOON FRAGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORONARY DILATION CATHETER DILATION CATHETER LOX ADVANCED CARDIOVASCULAR SYSTEMS, INC. 2.0 X 20, 135 CM 6011651

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention