BEUDAMED
    FDA Adverse Event Death Summary report: N

    TITANIUMDOME PORT W/ATT OPEN-ENDED 9.6 FR CATH

    MDR report key: 137437 · Received January 3, 1997

    Report

    Report Number
    1720496-1997-00008
    Event Type
    Death
    Date Received
    January 3, 1997
    Date of Event
    November 11, 1996
    Report Date
    November 19, 1996
    Manufacturer
    BARD ACCESS INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    9.6 FR VENOUS PORTACATH INSERTED UNDER FLUOROSCOPIC VISUALIZATION. AT PROCEDURE COMPLETION, PT BECAME DIAPHORETIC WITH DECREASE IN BLOOD PRESSURE AND PULSE RATE. ANESTHESIA ATTEMPTED TO INCREASE HEART RATE. FAMILY ATTEMPTED TO INCREASE HEART RATE. FAMILY CONSULTED AND RESUSCITATIVE EFFECTS DISCONTINUED DUE TO LENGTH OF EXTREME HYPOTENSION AND ADVANCE METASTATIC DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITANIUMDOME PORT W/ATT OPEN-ENDED 9.6 FR CATH Implant INTRAVASCULAR IMPLANTED PORT LJT BARD ACCESS INC. 0602870 361F0364

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death PORT.| 7/17/95: 9.6 FR. HICKMAN CATHETER, LOT# 36DF6321,| CODE #0602270, IMPLANTED. 5-23-96: EXPLANTED ABOVE