BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-TECH

    MDR report key: 471461 · Received July 15, 2003

    Report

    Report Number
    471461
    Event Type
    Malfunction
    Date Received
    July 15, 2003
    Date of Event
    June 10, 2003
    Report Date
    July 15, 2003
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    DQT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE, BALLOON WOULD NOT DEFLATE. IT WAS RETRIEVED INTACT WITH NO HARM TO THE PT. FACILITY HAD 2 SUCH BALLOONS. THE DEFECTIVE ONE, AS WELL AS THE UNUSED ONE, WERE RETURNED TO THE REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-TECH STANDARD OCCLUSION BALLOON CATHETER DQT BOSTON SCIENTIFIC CORP REF 17-500 M001175000 4507191

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR