BEUDAMED
    FDA Adverse Event Death Summary report: N

    BALLOON DILATATION CATHETER

    MDR report key: 20701 · Received March 10, 1995

    Report

    Report Number
    20701
    Event Type
    Death
    Date Received
    March 10, 1995
    Date of Event
    February 21, 1995
    Report Date
    March 3, 1995
    Manufacturer
    MEDI-TECH, INC.
    Product Code
    LIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ANGIOPLASTY, A BALLOON DILATATION CATHETER WAS ADVANCED INTO THE DISTAL ABDOMINAL AORTA. A SINGLE DILATATION WAS PERFORMED AT 8 ATMOSPHERES, AT WHICH POINT THE BALLOON RUPTURED. IT WAS REMOVED AND PT COMPLAINED OF BACK DISCOMFORT. FOUND TO HAVE FREE FLOW OF BLOOD. THE DISTAL ABDOMINAL AORTA RUPTURED WITH FREE FLOW OF BLOOD INTO RETROPERITONEAL SPACE. BALLOON WAS IMMEDIATELY REMOVED. UNCLEAR AS TO WHETHER OR NOT THE INCIDENT WITH THE BALLOON WAS DIRECTLY RELATED TO THE RUPTURING OF THE AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLOON DILATATION CATHETER CATHETER LIT MEDI-TECH, INC. PE-MT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death