BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM

    MDR report key: 472308 · Received July 16, 2003

    Report

    Report Number
    2134280-2003-00003
    Event Type
    Injury
    Date Received
    July 16, 2003
    Date of Event
    June 17, 2003
    Report Date
    July 16, 2003
    Manufacturer
    SUB-Q, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT CATHETERIZATION AT THE CONCLUSION OF THE CATHERIZATION PROCEDURE, A QUICKSEAL DEVICE WAS USED TO ACHIEVE HEMOSTASIS AT THE ARTERIAL PUNCTURE SITE. HEMOSTATSIS WAS OBTAINED IN 5 MINUTES WITH NO OBSERVABLE HEMATOMA OR BLEEDING AT THE SITE. PEDAL PULSE WAS CHECKED PRE-DEPLOYMENT AND IMMEDIATELY AFTER DEPLOYMENT. ALL PEDAL PULSES WERE INDENTICAL. AN HOUR POST DEPLOYMENT OF THE QUICKSEAL DEVICE, THE PATIENT DEVELOPED A COLD FOOT, THOUGH PEDAL PULSE WAS NOT COMPLETELY ABSENT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention