BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSEAL CONTROL

    MDR report key: 505918 · Received January 9, 2004

    Report

    Report Number
    2134280-2004-00001
    Event Type
    Injury
    Date Received
    January 9, 2004
    Date of Event
    December 12, 2003
    Report Date
    January 8, 2004
    Manufacturer
    SUB-Q, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT INDERWENT CATHERIZATION IN 2003. AT THE CONCLUSION OF THE PROCEDURE, A QUICKSEAL CONTROL DEVICE WAS USED TO PROVIDE HEMOSTASIS AT THE ARTERIAL PUNCTURE SITE. DURING THE USE OF THE DEPTH MARKER TO MEASURE ARTERY DEPTH, IT WAS FELT/NOTED THAT THE TIP BECAME FIXED AT THE ARTERY. THE CLINICAN ATTEMPTED TO WITHDRAW THE DEPTH MARKER, BUT THE TIP ELONGATED AND EVENTUALLY SEPARATED AT THE TIP BODY LEAVING THE DISTAL END OF THE TIP PARTIALLY IN THE ARTERY. FOLLOW-UP SURGERY WAS PERFORMED ON THE SAME DAY AND THE SEPARATED TIP WAS SUCCESSFULLY REMOVED FROM THE PT. THE PT WAS DISCHARGED IN 12/03 AND NO FURTHER RELATED EVENTS WERE EXPERIENCED BY THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSEAL CONTROL VASCULAR HEMOSTASIS DEVICE MGB SUB-Q, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention