BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROPHOCAN CVS CATHETER

    MDR report key: 57129 · Received December 20, 1996

    Report

    Report Number
    1217052-1996-00093
    Event Type
    Injury
    Date Received
    December 20, 1996
    Date of Event
    June 30, 1996
    Report Date
    November 21, 1996
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Product Code
    LLX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT THE CVS PROCEDURE AT 11.5 WEEKS GESTATION. ONE TRANSCERVICAL PASS WAS MADE. THE PT BEGAN BLEEDING TWO HOURS POAT PROCEDURE AND NO FETAL CARDIAC ACTIVITY WAS DETECTED. THE LACK OF FETAL CARDIAC ACTIVITY WAS CONFIRMED ON DAY POST PROCEDURE AND NO FETAL CARDIAC ACTIVITY WAS DETECTED. THE LACK OF FETAL CARDIAC ACTIVITY WAS CONFIRMED ONE DAY POST CVS AND A D & C WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROPHOCAN CVS CATHETER CATHETER, SAMPLING, CHORIONIC VILLUS LLX SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention A SYRINGE.