BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDITECH

    MDR report key: 10340 · Received November 9, 1993

    Report

    Report Number
    10340
    Event Type
    Injury
    Date Received
    November 9, 1993
    Date of Event
    October 12, 1993
    Report Date
    October 15, 1993
    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

    DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A PIECE OF THE BALLOON REMAINED IN THE VESSEL AFTER THE BALLOON WAS REMOVED (THE LEFT ILIAC). A STENT WAS IMPLANTED OVER THE PIECE OF BALLOON TO PREVENT AN EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDITECH Implant BALLOON CATHETER LIT MEDI-TECH, INC. PE-MT/8-3/5/75

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention