BEUDAMED
    FDA Adverse Event Summary report: N

    CORDIS LUMEND OUTBACK LTD RE-ENTRY CATHETER

    MDR report key: 1141905 · Received August 28, 2008

    Report

    Report Number
    MW5008130
    Date Received
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    CORDIS
    Product Code
    DQY
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CORDIS IS RECALLING ALL LOTS OF THE LUMEND OUTBACK LTD. RE-ENTRY CATHETER CATALOG NUMBER OTB42120. 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. SEE SCANNED PAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS LUMEND OUTBACK LTD RE-ENTRY CATHETER NONE DQY CORDIS 13393132
    2 CORDIS LUMEND OUTBACK LTD RE-ENTRY CATHETER NONE DQY CORDIS 13402180

    Patients

    Seq Age Sex Outcome Treatment
    1