BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERPORT ISP M.R.I. IMPLANTABLE PORT

    MDR report key: 4490181 · Received February 3, 2015

    Report

    Report Number
    3006260740-2015-00048
    Event Type
    Death
    Date Received
    February 3, 2015
    Date of Event
    January 7, 2015
    Report Date
    January 20, 2015
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    LJT
    PMA / PMN Number
    K063377
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS INSERTED INTO A (B)(6) FEMALE PT FOR RECTAL CANCER CHEMOTHERAPY VIA THE RIGHT SUBCLAVIAN VEIN UNDER FLUOROSCOPY WITH PRIOR ULTRASOUND ASSESSMENT AND ACCESS SITE MARKING OF THE SKIN. DURING THE PLACEMENT PROCEDURE, THE PT REPORTEDLY FELT SICK. WHEN CONTRACT MEDIUM WAS INJECTED FROM THE CATHETER, LEAKAGE INTO THE LEFT MEDIASTINUM WAS ALLEGEDLY CONFIRMED. CT WAS PERFORMED TO CHECK THE PLACEMENT OF THE CATHETER. IT WAS REPORTED THAT SUBSEQUENT SURGICAL OPERATION FOUND PERFORATION OF THE SUPERIOR VENA CAVA. FURTHER DETAILS ARE UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77441 POWERPORT ISP M.R.I. IMPLANTABLE PORT LJT BARD ACCESS SYSTEMS INC. NP

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death