BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-TECH 6 MM ANGIOPLASTY BALLOON CATHETER

    MDR report key: 16403 · Received July 11, 1994

    Report

    Report Number
    16403
    Event Type
    Malfunction
    Date Received
    July 11, 1994
    Date of Event
    June 27, 1994
    Report Date
    July 5, 1994
    Manufacturer
    MEDI-TECH, INC.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A FISTULOGRAM OF THE PT'S AV GRAFT SHOWED A STENOSIS AT THE VENOUS ANASTOMOSIS. AN ANGIOPLASTY WAS DONE OVER THE STENOSIS. THEN A THROMBOLYSIS WAS PERFORMED WITH 250,000 UNITS OF UROKINASE. A REPEAT ANGIOPLASTY WAS PERFORMED AND THE BALLOON BURST. WHILE WITHDRAWING THE BALLOON THROUGH THE SHEATH, A SMALL DISTAL PART OF THE BALLOON BROKE OFF IN THE GRAFT. A REPEAT FISTULOGRAM DID NOT SHOW THE BALLOON. A SURGICAL THROMBECTOMY WAS PERFORMED THE FOLLOWING DAY AND THE BROKEN BALLOON REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-TECH 6 MM ANGIOPLASTY BALLOON CATHETER ANGIOPLASTY BALLOON CATHETER LIT MEDI-TECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other