BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCIMED IVUS 40 MHZ 2.6F

    MDR report key: 225922 · Received June 3, 1999

    Report

    Report Number
    225922
    Event Type
    Injury
    Date Received
    June 3, 1999
    Date of Event
    May 24, 1999
    Report Date
    June 2, 1999
    Manufacturer
    SCIMED B210 BOSTON SCIENTIFIC CORP.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING REMOVAL OF IVUS ULTRA SOUND SHEATH, DISTAL END BROKE OFF, LODGING IN THE LEFT CIRCUMFLEX ARTERY AND AORTA. REQUIRED SURGICAL INTERVENTION TO REMOVE THE CATHETER. RETAINED PORTION WAS APPROX 8-10 INCHES IN LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCIMED IVUS 40 MHZ 2.6F Implant CORONARY IMAGING CATHETER DQO SCIMED B210 BOSTON SCIENTIFIC CORP. C3020 2343735

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention