BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT

    MDR report key: 9124191 · Received September 26, 2019

    Report

    Report Number
    2020394-2019-03543
    Event Type
    Injury
    Date Received
    September 26, 2019
    Date of Event
    February 22, 2018
    Report Date
    October 8, 2019
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K133948
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW 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. JOURNAL ARTICLE CITATION: WANG, X., LV, Y., XU, Z., ANIU, M., QIU, Y., WEI, B., ¿ LIN, T. (2018). ACCURACY AND SAFETY OF ULTRASOUND-GUIDED PERCUTANEOUS NEEDLE CORE BIOPSY OF RENAL MASSES. MEDICINE, 97(13). DOI: 10.1097/MD.0000000000010178

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN WOLTER KLUWER HEALTH INC., ¿ACCURACY AND SAFETY OF ULTRASOUND-GUIDED PERCUTANEOUS NEEDLE CORE BIOPSY OF RENAL MASSES: A SINGLE CENTER EXPERIENCE IN CHINA¿, THAT DURING A RETROSPECTIVE REVIEW OF 106 RENAL MASS BIOPSY PERFORMED, ONE PATIENT EXPERIENCED HEMORRHAGE, WHICH REQUIRED A TRANSFUSION OF PACKED ERYTHROCYTES. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW 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. JOURNAL ARTICLE CITATION: WANG, X., LV, Y., XU, Z., ANIU, M., QIU, Y., WEI, B., ¿ LIN, T. (2018). ACCURACY AND SAFETY OF ULTRASOUND-GUIDED PERCUTANEOUS NEEDLE CORE BIOPSY OF RENAL MASSES. MEDICINE, 97(13). DOI: 10.1097/MD.0000000000010178. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN WOLTER KLUWER HEALTH INC., ¿ACCURACY AND SAFETY OF ULTRASOUND-GUIDED PERCUTANEOUS NEEDLE CORE BIOPSY OF RENAL MASSES: A SINGLE CENTER EXPERIENCE IN CHINA¿, THAT DURING A RETROSPECTIVE REVIEW OF 106 RENAL MASS BIOPSY PERFORMED, ONE PATIENT EXPERIENCED HEMORRHAGE, WHICH REQUIRED A TRANSFUSION OF PACKED ERYTHROCYTES. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916513 BARD MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention