BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT

    MDR report key: 2383993 · Received December 15, 2011

    Report

    Report Number
    2522007-2011-00019
    Event Type
    Death
    Date Received
    December 15, 2011
    Date of Event
    November 25, 2011
    Report Date
    December 12, 2011
    Manufacturer
    COOK VASCULAR INC
    Product Code
    LJT
    PMA / PMN Number
    K931586
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO THE COMPLAINT COMMUNICATION FORM, PRODUCT IS NOT BEING RETURNED FOR EVAL. PRODUCT NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    CATHETER DISLOCATED AND MIGRATED TO THE HEART. PORT WAS REMOVED. PT DIED DURING/AFTER EXPLANT PROCEDURE. PER COMPLAINTS FORM: THEY HAVE IMPLANTED A PERIPHERAL PORT CATHETER DEVICE. AFTER THE PROCEDURE, IT LOOK LIKE ALL VERY WELL, BUT ON THE WARD THE PORT DOESN'T WORK. SO THEY MADE A OVERVIEW AND THE PORT CATHETER WAS DISLOCATED IN THE RIGHT HEART, SO THEY STARTED TO RETRIEVE THE CATHETER IN THE CATH LAB AND REMOVE THE PORT CHAMBER. DURING THIS, THEY RUPTURED THE FEMORAL VEIN AND THE PT GET WORSE SO THEY HAVE TO REANIMATE BUT WITH NO GOOD RESULT THE PT DIED. CATHETER SECTION WAS REMOVED USING A SNARE OVER A LONG SHEATH THROUGH THE FEMORAL VEIN. ADD'L PROCEDURE: PORT EXPLANT. PT DIED DURING/AFTER EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER LJT COOK VASCULAR INC IP-S5116W-MPIS-NT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death