BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GHIATAS

    MDR report key: 22316628 · Received June 24, 2025

    Report

    Report Number
    2020394-2025-00938
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    May 22, 2025
    Report Date
    September 22, 2025
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    GDF
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: AS THIS SERIOUS INJURY IS CONSIDERED ONE EVENT IDENTIFIED BY THE DEALER; ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THE REPORTED QUANTITY AFFECTED OF NINETEEN FOR THIS EVENT. SARAH MARTAINDALE, MARION SCOGGINS, ROLAND L BASSETT JR, GARY WHITMAN (2022). RETAINED LOCALIZATION WIRE FRAGMENTS IN THE BREAST: LONG-TERM FOLLOW-UP. CURRENT PROBLEMS IN DIAGNOSTIC RADIOLOGY, 51(3):313-316. DOI: 10.1067/J.CPRADIOL.2021.03.015. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL 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. 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.

    Additional Manufacturer Narrative · 0

    H11: AS THIS SERIOUS INJURY IS CONSIDERED ONE EVENT IDENTIFIED BY THE DEALER; ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THE REPORTED QUANTITY AFFECTED OF NINETEEN FOR THIS EVENT. SARAH MARTAINDALE, MARION SCOGGINS, ROLAND L BASSETT JR, GARY WHITMAN (2022). RETAINED LOCALIZATION WIRE FRAGMENTS IN THE BREAST: LONG-TERM FOLLOW-UP. CURRENT PROBLEMS IN DIAGNOSTIC RADIOLOGY, 51(3):313-316. DOI: 10.1067/J.CPRADIOL.2021.03.015. MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. 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 REPORTED DETACHMENT OF DEVICE OR DEVICE COMPONENT COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. B5, G3, H6 (COMPONENT, METHOD). 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 "CURRENT PROBLEMS IN DIAGNOSTIC RADIOLOGY" TITLED "RETAINED LOCALIZATION WIRE FRAGMENTS IN THE BREAST: LONG-TERM FOLLOW-UP", THAT A STUDY IDENTIFIED 19 RETAINED BREAST LOCALIZATION WIRE FRAGMENTS IN 18 PATIENTS. EIGHT PATIENTS UNDERWENT EXCISION OF THE RETAINED FRAGMENT, BUT NONE WERE REMOVED DUE TO MIGRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED IN ARTICLE IN THE JOURNAL, "CURRENT PROBLEMS IN DIAGNOSTIC RADIOLOGY" TITLED, "RETAINED LOCALIZATION WIRE FRAGMENTS IN THE BREAST: LONG-TERM FOLLOW-UP" THAT TOTAL OF 18 ELIGIBLE PATIENTS WERE IDENTIFIED WITH A TOTAL OF 19 RETAINED LOCALIZATION WIRE FRAGMENTS. EIGHT FRAGMENTS WERE SURGICALLY EXCISED, THOUGH NONE WERE EXCISED DUE TO MIGRATION. FIVE OF THE 8 CASES UNDERGOING EXCISION WERE WIRE LOCALIZATION FRAGMENTS IDENTIFIED FOLLOWING SURGICAL EXCISIONS AT OUTSIDE INSTITUTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390563 GHIATAS BREAST LOCALIZATION WIRE GDF BARD PERIPHERAL VASCULAR, INC. REJS2707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention