BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HSH FRENCH CATHETER 6.5

    MDR report key: 26615 · Received August 3, 1995

    Report

    Report Number
    26615
    Event Type
    Injury
    Date Received
    August 3, 1995
    Date of Event
    June 1, 1995
    Report Date
    June 1, 1995
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ARTERIOGRAM, NO BLOOD RETURNED FROM THE CEREBRAL CATHETER. FLUOROSCOPY SHOWED KINKING (LOOP)-UNABLE TO STRAIGHTEN CATHETER OUT BY USING STANDARD MANIPULATION TECHNIQUE. CATHETER WAS PULLED OUT BY PHYSICIAN-POST PROCEDURE-NO FEMORAL PULSE LEG PAIN NOTED. PT WAS SENT TO O.R. FOR EMBOLELCTOMY. DISCHARGED TO HOME ON 6/2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HSH FRENCH CATHETER 6.5 CEREBRAL HEAD HUNTER CATHETER DQO COOK, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention