BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSEAL ARTERIAL CLOSURE SYSTEM

    MDR report key: 498294 · Received October 27, 2003

    Report

    Report Number
    498294
    Event Type
    Injury
    Date Received
    October 27, 2003
    Date of Event
    June 1, 2003
    Report Date
    July 1, 2003
    Manufacturer
    SUB-Q, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE FEMORAL ARTERIOTOMY SITE WAS CLOSED USING SUB-Q QUICKSEAL. THE PT WAS TRANSFERRED TO THE "I&O" AREA WHERE THEY COMPLAINED OF RIGHT LEG BEING NUMB AND PALE IN COLOR. THE PT WAS TAKEN BACK TO THE VASCULAR LAB. ACCESS WAS OBTAINED VIA THE BRACHIAL ARTERY AND PICTURES TAKEN. THE VESSEL WAS THROMBOSED AT THE PUNCTURE SITE. UNDERWENT AN ANGIO-JET OF THE RIGHT COMMON FEMORAL ARTERY SUCCESSFULLY WITH THE USE OF A DISTAL EMBOLI PROTECTION DEVICE. PT TOLERATED THE PROCEDURE WELL WITH THE RETURN OF NORMAL FLOW OF THE RIGHT LEG AND NO EVIDENCE OF DISTAL EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSEAL ARTERIAL CLOSURE SYSTEM CLOSURE DEVICE MGB SUB-Q, INC. Q100 R921554J-1

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R