BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC CORP.

    MDR report key: 539721 · Received August 12, 2004

    Report

    Report Number
    1317056-2004-00024
    Event Type
    Malfunction
    Date Received
    August 12, 2004
    Date of Event
    June 22, 2004
    Report Date
    July 13, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY DISTRIBUTOR, TUBING FROM A FLUID DELIVERY SET IN A CONVENIENCE KIT IS KINKED, MAKING IT DIFFICULT TO ASPIRATE CONTRAST AND CREATING MICROBUBBLES. THERE HAS BEEN NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORP. CONVENIENCE KIT DTL BOSTON SCIENTIFIC NA 569445

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN