BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIGHTHAWK DIAGNOSTIC CATHETER

    MDR report key: 180678 · Received July 31, 1998

    Report

    Report Number
    6000058-1998-00040
    Event Type
    Injury
    Date Received
    July 31, 1998
    Date of Event
    May 20, 1998
    Report Date
    July 17, 1998
    Manufacturer
    MEDI-TECH/A DIV OF BOSTON SCIENTIFIC
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE THE PT EXPERIENCED APHASIA, AND RIGHT SIDE HEMIPLEGIA. THE PROCEDURE WAS STOPPED. PT STATUS IS LISTED AS "CRITICAL". IT IS UNCLEAR HOW THE CATHETER PERFORMANCE IS RELATED TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIGHTHAWK DIAGNOSTIC CATHETER DIAGNOSTIC CATHETER DQO MEDI-TECH/A DIV OF BOSTON SCIENTIFIC NHTS/5/WEIN/035/100/NS BX/5 1230064

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention