BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMEND OUTBACK LTD RE-ENTRY CATHETER

    MDR report key: 1155971 · Received September 9, 2008

    Report

    Report Number
    MW5008250
    Event Type
    Other
    Date Received
    September 9, 2008
    Report Date
    August 19, 2008
    Manufacturer
    CORDIS
    Product Code
    DQY
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PURPOSE OF THIS LETTER IS TO INFORM YOU THAT CORDIS IS RECALLING ALL LOTS OF THE LUMEND OUTBACK LTD RE-ENTRY CATHETER. CORDIS RECENTLY DETERMINED THAT THE SEPARATION RATE OF THE CANNULA TO THE DEPLOYMENT SLIDE OF THE HANDLE ASSEMBLY OF THE LUMEND OUTBACK LTD RE-ENTRY CATHETER IS HIGHER THAN ANTICIPATED. THE POTENTIAL RESULT OF SUCH A SEPARATION IS INABILITY TO RETRACT THE CANNULA NEEDLE INTO THE CANNULA BODY. IF A SEPARATION OF THE CANNULA AND THE DEPLOYMENT SLIDE OF THE HANDLE ASSEMBLY WERE TO OCCUR DURING USE, AND THE CANNULA TIP REMAINED EXTENDED, THE DEVICE MAY NEED TO BE REMOVED PERCUTANEOUSLY WITH THE NEEDLE IN THE DEPLOYED POSITION OR VIA SURGICAL EXTRACTION. IN SUCH CASES, VASCULAR INJURY IS A POSSIBILITY. IF A PROCEDURE HAS BEEN COMPLETED SUCCESSFULLY USING THE PRODUCT, THERE IS NO CONCERN. IN KEEPING WITH OUR COMMITMENT TO PROVIDE CUSTOMERS WITH QUALITY PRODUCTS, CORDIS HAS VOLUNTARILY DECIDED TO RECALL ALL LOTS OF THE LUMEND OUTBACK LTD RE-ENTRY CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMEND OUTBACK LTD RE-ENTRY CATHETER RE-ENTRY CATHETER DQY CORDIS 2052AA

    Patients

    Seq Age Sex Outcome Treatment
    1