BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM

    MDR report key: 466312 · Received June 5, 2003

    Report

    Report Number
    2134280-2003-00002
    Event Type
    Injury
    Date Received
    June 5, 2003
    Date of Event
    May 2, 2003
    Report Date
    June 5, 2003
    Manufacturer
    SUB-Q, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT CARDIAC CATHETERIZATION AT 10:18 AM. AT THE CONCLUSION OF THE CATHETERIZATION PROCEDURE (AT 10:30 AM), A QUICKSEAL DEVICE WAS USED TO ACHIEVE HEMOSTASIS AT THE ARTERIAL PUNCTURE SITE IN THE RIGHT GROIN. HEMOSTASIS WAS OBTAINED IN 3 MINUTES WITH NO OBSERVABLE HEMATOMA OR BLEEDING AT THE SITE. PEDAL PULSE WAS CHECKED PRE-DEPLOYMENT; IMMEDIATELY AFTER DEPLOYMENT AND WAS LATER CHECKED 1-HOUR POST DEPLOYMENT OF THE QUICKSEAL DEVICE. ALL PEDAL PULSES WERE IDENTICAL. AT AMBULATION (1:45 PM), THE PATIENT EXPERIENCED PAIN BEHIND THE KNEE FOLLOWED BY A COLD FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM VASCULAR HEMOSTASIS DEVICE MGB SUB-Q, INC. NA R911294J-1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention