BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GHIATAS

    MDR report key: 16699795 · Received April 7, 2023

    Report

    Report Number
    2020394-2023-00234
    Event Type
    Injury
    Date Received
    April 7, 2023
    Date of Event
    May 20, 2022
    Report Date
    August 25, 2023
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    GDF
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: WEN QIN, JUN GE, ZHIHAO GONG, YUNYUN ZHANG, DAVID M DIBARDINO, ANDREA IMPERATORI, ET. AL.(2022). THE INCIDENCE AND RISK FACTORS OF ACUTE PAIN AFTER PREOPERATIVE NEEDLE LOCALIZATION OF PULMONARY NODULES: A CROSS-SECTIONAL STUDY. TRANSLATIONAL LUNG CANCER RESEARCH, 11(8):1667-1677. DOI: 10.21037/TLCR-22-557. 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.

    Additional Manufacturer Narrative · 0

    H10: WEN QIN, JUN GE, ZHIHAO GONG, YUNYUN ZHANG, DAVID M DIBARDINO, ANDREA IMPERATORI, ET. AL.(2022). THE INCIDENCE AND RISK FACTORS OF ACUTE PAIN AFTER PREOPERATIVE NEEDLE LOCALIZATION OF PULMONARY NODULES: A CROSS-SECTIONAL STUDY. TRANSLATIONAL LUNG CANCER RESEARCH, 11(8):1667-1677. DOI: 10.21037/TLCR-22-557. H10: 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 ALLEGED ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. 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 JOURNAL OF ¿TRANSLATIONAL LUNG CANCER RESEARCH¿ TITLED ¿THE INCIDENCE AND RISK FACTORS OF ACUTE PAIN AFTER PREOPERATIVE NEEDLE LOCALIZATION OF PULMONARY NODULES: A CROSS-SECTIONAL STUDY" THAT SOMETIME POST PROCEDURE, TWO HUNDRED AND SIXTY-SIX OF THREE HUNDRED PATIENTS REPORTEDLY EXPERIENCED PAIN DURING DEEP BREATHING AND CHEST MOVEMENT ANALYSIS OF PAIN CHARACTERISTICS. FURTHERMORE, SIXTEEN OF THREE HUNDRED PATIENTS WERE TREATED WITH CYCLOOXYGENASE-2 INHIBITORS WITHOUT PERCEPTIBLE PAIN RELIEF. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN JOURNAL OF ¿TRANSLATIONAL LUNG CANCER RESEARCH¿ TITLED ¿THE INCIDENCE AND RISK FACTORS OF ACUTE PAIN AFTER PREOPERATIVE NEEDLE LOCALIZATION OF PULMONARY NODULES: A CROSS-SECTIONAL STUDY" THAT SOMETIME POST OFF-LABEL USE OF LOCALIZATION HOOK-WIRE, TWO HUNDRED AND SIXTY-SIX OF THREE HUNDRED PATIENTS ALLEGEDLY EXPERIENCED MODERATE TO SEVERE PAIN DURING DEEP BREATHING AND CHEST MOVEMENT ANALYSIS OF PAIN CHARACTERISTICS. REPORTEDLY, SIXTEEN OF THREE HUNDRED PATIENTS HAVE BEEN ADMINISTERED WITH THE CYCLOOXYGENASE-2 INHIBITORS WITHOUT PERCEPTIBLE PAIN RELIEF. THE PATIENTS CURRENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730477 GHIATAS BREAST LOCALIZATION WIRE GDF BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention