BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXCORE

    MDR report key: 17230568 · Received June 29, 2023

    Report

    Report Number
    2020394-2023-00467
    Event Type
    Death
    Date Received
    June 29, 2023
    Date of Event
    February 1, 2018
    Report Date
    June 6, 2023
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K133948
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: DATE OF DEATH FOR THIS PATIENT WAS NOT PROVIDED, DATE OF DEATH UPDATED AS 01-JAN-1900 FOR THE MDR SUBMISSION REQUIREMENT. H10: M E PÉREZ MONTILLA, S LOMBARDO GALERA, J J ESPEJO HERRERO, J M SASTOQUE AND L ZURERA TENDERO (2018). DIAGNOSTIC PERFORMANCE OF IMAGING-GUIDED CORE NEEDLE BIOPSY OF THE MESENTERY AND PERITONEUM. RADIOLOGÍA, 60(2):128-135. DOI: 10.1016/J.RX.2017.12.003. 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 PROVIDED BY BD REPRESENTS ALL OF 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN JOURNAL OF ¿RADIOLOGIA ENGLISH EDITION¿ TITLED ¿DIAGNOSTIC PERFORMANCE OF IMAGING-GUIDED CORE NEEDLE BIOPSY OF THE MESENTERY AND PERITONEUM" THAT SOMETIME POST PROCEDURE, ONE PATIENT OUT OF FIFTY-SEVEN EXPERIENCED ACTIVE BLEEDING IN THE ANTERIOR RECTUS MUSCLE, PROBABLY COMING FROM THE EPIGASTRIC ARTERY. REPORTEDLY, AN EMBOLIZATION PROCEDURE WAS ATTEMPTED THROUGH ENDOVASCULAR ACCESS. HOWEVER, THE PATIENT REPORTEDLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527693 MAXCORE BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death