BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK, INC.

    MDR report key: 375331 · Received February 6, 2002

    Report

    Report Number
    375331
    Event Type
    Injury
    Date Received
    February 6, 2002
    Date of Event
    October 15, 2001
    Report Date
    December 31, 2001
    Manufacturer
    COOK, INC.
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AORTIC ARCH/CAROTID ANGIOGRAM/EMBOLIZATION OF LARGE PSEUDOANEURYSM RIGHT PROFUNDA FEMORIS ARTERY, A 5MM COIL WAS DEPLOYED PROXIMALLY AND SNARED BUT COULD NOT BE DRAWN BACK INTO SHEATH. SUBSEQUENTLY PLACED INTO LEFT SUPERFICIAL FEMORAL ARTERY WHICH HAD BEEN PREVIOUSLY CHRONICALLY OCCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK, INC. COIL KRD COOK, INC. MWCE-38-5-5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR