BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA

    MDR report key: 4939695 · Received July 13, 2015

    Report

    Report Number
    2032582-2015-00001
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 13, 2015
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    LJT
    PMA / PMN Number
    K072481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INVESTIGATION COULD BE DETERMINED SINCE THE PRODUCT WAS NOT RETURNED. NO OTHER COMPLAINTS WERE FILED AGAINST THIS LOT NUMBER. ALL DOCUMENTS OF THE DHR WERE COMPLETE AND IN ORDER.

    Description of Event or Problem · 1

    EVENT DESC: IT WAS DETERMINED THAT THE XCELA PORT WAS NOT WORKING (BEING ACCESSED FOR CHEMO). CATHETER DETACHED AND MIGRATED TO THE HEART. WAS SUCCESSFULLY REMOVED BY DR. (B)(6) (INTERVENTIONAL RADIOLOGY) ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454098 XCELA CATHETER, INTRAVASCULAR, THERAPEUTIC LJT PFM MEDICAL, INC 134811000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention