BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATH TEMPO 5 SIDEWINDER II 100

    MDR report key: 680670 · Received February 27, 2006

    Report

    Report Number
    9616099-2006-00201
    Event Type
    Injury
    Date Received
    February 27, 2006
    Date of Event
    July 30, 2005
    Report Date
    February 27, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CATHETER WAS INTRODUCED INTO THE TARGET ARTERY, BUT THEN THE PHYSICIAN FELT SOMETHING AND HE TRIED TO REMOVE THE CATHETER. IT WAS REPORTED THAT ONLY PART OF THE CATHETER COULD BE REMOVED, AND THE OTHER PART WAS TAKEN OUT VIA VASCULAR SURGERY. THERE WAS NO REPORTED ADVERSE OUTCOME. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH TEMPO 5 SIDEWINDER II 100 DIAGNOSTIC ENDOVASCULAR CATHETERS DQO CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention