BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SITESEER-6F JR 5.0 100CM DX CATHETER

    MDR report key: 514669 · Received March 4, 2004

    Report

    Report Number
    1220452-2004-00027
    Event Type
    Injury
    Date Received
    March 4, 2004
    Date of Event
    December 10, 2003
    Report Date
    January 9, 2004
    Manufacturer
    MEDTRONIC VASCULAR, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO THE CO THAT DURING THE PROCEDURE A DISSECTION OF THE VESSEL WAS NOTICED. THE PHYSICIAN INSERTED THE ANGIOGRAPHIC CATHETER INTO THE PT INTO THE RIGHT CORONARY ARTERY. THE PHYSICIAN INJECTED DYE INTO THE VESSEL AND TOOK CINEANGIOGRAPHY OF THE VESSEL. THE ANGIOGRAPHY SHOWED A DISSETION OF THE VESSEL. THE PHYSICIAN STENTED THE VESSEL TO REPAIR THE DAMAGE. THE RESULTS WERE GOOD AND PT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITESEER-6F JR 5.0 100CM DX CATHETER DIAGNOSTIC CATHETERS DQO MEDTRONIC VASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN