BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK

    MDR report key: 1845024 · Received September 22, 2010

    Report

    Report Number
    MW5017575
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 22, 2010
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON ATTEMPT TO REMOVE A 3 FRENCH 10CM CATHETER FROM LEFT FEMORAL ARTERY, THE CATHETER BROKE OFF AT THE HUB WITHOUT ANY FORCIBLE RESISTANCE LEAVING THE ENTIRE CATHETER INSIDE PT'S FEMORAL ARTERY. THE PT WAS TAKEN TO THE CATH LAB, ANESTHETIZED AND INTUBATED. SURGEON PERFORMED A CUT-DOWN OF THE LEFT FEMORAL ARTERY AND THE PIECE WAS RETRIEVED INTACT AND WITHOUT COMPLICATION. THE PT WAS EXTUBATED AND RECOVERED WITHOUT INCIDENT. DATES OF USE: (B)(6)2010 - (B)(6)2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK 3 FRENCH 10CM ARTERIAL CATHETER DQX

    Patients

    Seq Age Sex Outcome Treatment
    1 17 MO Disability