BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISSION KIT

    MDR report key: 22746579 · Received August 8, 2025

    Report

    Report Number
    2020394-2025-01204
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    September 10, 2020
    Report Date
    October 13, 2025
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K171953
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: 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. DEY M, DAS S, CHATTERJEE A, DUTTA A, GHOSH R, DASGUPTA J. YIELD AND SAFETY OF TRANSJUGULAR VERSUS PERCUTANEOUS LIVER BIOPSIES IN SUSPECTED CASES OF DIFFUSE LIVER DISEASE AND CORRELATION OF YIELD OF TRANSJUGULAR LIVER BIOPSY WITH HEPATIC VENOUS PRESSURE GRADIENT. JOURNAL OF GASTROINTESTINAL AND ABDOMINAL RADIOLOGY. 2021 JAN;4(01):003-7. 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.

    Additional Manufacturer Narrative · 0

    H11: DEY M, DAS S, CHATTERJEE A, DUTTA A, GHOSH R, DASGUPTA J. YIELD AND SAFETY OF TRANSJUGULAR VERSUS PERCUTANEOUS LIVER BIOPSIES IN SUSPECTED CASES OF DIFFUSE LIVER DISEASE AND CORRELATION OF YIELD OF TRANSJUGULAR LIVER BIOPSY WITH HEPATIC VENOUS PRESSURE GRADIENT. JOURNAL OF GASTROINTESTINAL AND ABDOMINAL RADIOLOGY. 2021 JAN;4(01):003-7. MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED IS UNKNOWN. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE FOR THE ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. B5, G3, H6 (PATIENT) SECTION A THROUGH F: THE INFORMATION PROVIDED 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

    RADIOLOGY" OF ARTICLE TITLED, "YIELD AND SAFETY OF TRANSJUGULAR VERSUS PERCUTANEOUS LIVER BIOPSIES IN SUSPECTED CASES OF DIFFUSE LIVER DISEASE AND CORRELATION OF YIELD OF TRANSJUGULAR LIVER BIOPSY WITH HEPATIC VENOUS PRESSURE GRADIENT", THAT SOMETIME LATER POST PERCUTANEOUS LIVER BIOPSY PROCEDURE TO COMPARE THE YIELD AND SAFETY OF TRANSJUGULAR VERSUS PERCUTANEOUS LIVER BIOPSIES, OUT OF NINETY SEVEN PATIENTS, THERE WERE ONE OCCURRENCE OF POST BIOPSY HEMOGLOBIN DROP, ONE OCCURRENCE OF HEMOPERITONEUM, TWELVE OCCURRENCES OF PAIN, FEVER, LOCAL SITE SWELLING. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN RESEARCH PAPER OF "INDIAN SOCIETY OF GASTROINTESTINAL AND ABDOMINAL RADIOLOGY" OF ARTICLE TITLED, "YIELD AND SAFETY OF TRANSJUGULAR VERSUS PERCUTANEOUS LIVER BIOPSIES IN SUSPECTED CASES OF DIFFUSE LIVER DISEASE AND CORRELATION OF YIELD OF TRANSJUGULAR LIVER BIOPSY WITH HEPATIC VENOUS PRESSURE GRADIENT", THAT SOMETIME LATER POST PERCUTANEOUS LIVER BIOPSY PROCEDURE TO COMPARE THE YIELD AND SAFETY OF TRANSJUGULAR VERSUS PERCUTANEOUS LIVER BIOPSIES, OUT OF NINETY SEVEN PATIENTS, THERE WERE ONE OCCURRENCE OF POST BIOPSY HEMOGLOBIN DROP, ONE OCCURRENCE OF HEMOPERITONEUM, TWELVE OCCURRENCES OF PAIN, FEVER, HEMATOMA. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497772 MISSION KIT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention