BEUDAMED
    FDA Adverse Event Death Summary report: N

    VAS-CATH

    MDR report key: 161155 · Received April 1, 1998

    Report

    Report Number
    161155
    Event Type
    Death
    Date Received
    April 1, 1998
    Date of Event
    January 22, 1998
    Report Date
    February 16, 1998
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LFJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 34 YEAR OLD WHITE FEMALE, 17 WEEKS PREGNANT WITH ANTIBODY DISORDER NEEDING PLASMAPHERESIS TO PREVENT DEATH TO FETUS. ON 1/21/98 A NON-FUNCTIONING PERMA VAS-CATH WAS REPLACED WITH ANOTHER PERMA VAS-CATH TO THE RIGHT SUBCLAVIAN. ON 1/22/98 THIS CATHETER WAS NO LONGER FUNCTIONING. UPON REMOVAL OF THIS CATHETER THE PT HEMORRHAGED, WAS TREATED AND TAKEN IMMEDIATELY TO THE OR, WHERE SHE EXPIRED. FURTHER EXPLORATION REVEALED A TEAR IN THE SUBCLAVIAN ARTERY, EXTRAPLEURAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAS-CATH Implant CENTRAL VENOUS CATHETER LFJ BARD ACCESS SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death