BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDITECH ULTRATHIN 5F ANGIOPLASTY CATHETER

    MDR report key: 35222 · Received July 25, 1996

    Report

    Report Number
    35222
    Event Type
    Injury
    Date Received
    July 25, 1996
    Date of Event
    March 12, 1996
    Report Date
    May 9, 1996
    Manufacturer
    MEDI-TECH, INC.
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED LT EXT ILIAC ANGIOPLASTY BUT WAS UNSUCCESSFUL DUE TO BALLOON CATHETER BREAK WITH FRAGMENT REMAINING IN VESSEL. THE CATHETER WAS SHEARED OFF AT A DENSELY CALCIFIED AORTIC BIFURCATION. PT WAS TAKEN TO SURGERY FOR EXTRACTION OF THIS FOREIGN BODY AND FOR ILIOFEMORAL BYPASS 3/14/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDITECH ULTRATHIN 5F ANGIOPLASTY CATHETER Implant ULTRATHIN 5F ANGIOPLASTY CATHETER LIT MEDI-TECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention