BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARQUEE

    MDR report key: 21052403 · Received January 2, 2025

    Report

    Report Number
    2020394-2024-01931
    Event Type
    Injury
    Date Received
    January 2, 2025
    Date of Event
    January 22, 2024
    Report Date
    December 6, 2024
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K133948
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: HEERA YOEN, HYUN-AH CHUNG, SO-MIN LEE, EUN-SUNG KIM, WOO KYUNG MOON, SU MIN HA (2023). HEMORRHAGIC COMPLICATIONS FOLLOWING ULTRASOUND-GUIDED BREAST BIOPSY: A PROSPECTIVE PATIENT-CENTERED STUDY. THE KOREAN SOCIETY OF RADIOLOGY. DOI: 10.3348/KJR.2023.0874. H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. H11: SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL "KOREAN JOURNAL OF RADIOLOGY" TITLED, "HEMORRHAGIC COMPLICATIONS FOLLOWING ULTRASOUND GUIDED BREAST BIOPSY: A PROSPECTIVE PATIENT-CENTERED STUDY", THAT POST BIOPSY PROCEDURE, OUT OF NINETY-FOUR PATIENTS, TWO OCCURRENCES OF BLEEDING. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387322 MARQUEE BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention