BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATEC 0912-12

    MDR report key: 21233057 · Received January 24, 2025

    Report

    Report Number
    1222780-2025-00037
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    December 5, 2024
    Report Date
    February 25, 2026
    Manufacturer
    HOLOGIC, INC
    Product Code
    KNW
    UDI-DI
    15420045504851
    PMA / PMN Number
    K042290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS CONDUCTED: IT WAS REPORTED THAT ON (B)(6) 2024, A PHYSICIAN REPORTED THAT SOMETIMES WHEN PERFORMING A BIOPSY WITH AN ATEC NEEDLE THEY NOTICED A PIECE OF MATERIAL PLASTIC IN BETWEEN THE SPECIMENS. PHYSICIAN PROVIDED A PICTURE IN WHICH IT CAN BE OBSERVED A PLASTIC PARTICLE MIXED ALONG WITH THE SAMPLES. THE PARTICLES WERE ONLY OBSERVED IN THE SAMPLES AND NOT IN THE PATIENTS. NO SAMPLES HAVE BEEN OBSERVED IN THE BREAST OF THE PATIENT. PHYSICIAN REPORTED THAT NO INJURY WAS REPORTED TO PATIENTS NOR USERS. THE DEVICE WAS RETURNED TO THE POST MARKET QUALITY LABORATORY FOR INVESTIGATION. VISUAL INSPECTION WAS CONDUCTED, AND THE COMPLAINANT SENT A BOTTLE WITH A SAMPLE THAT LOOKS LIKE A PLASTIC PIECE, AS EVIDENCE OF THE FOREIGN MATERIAL. DURING THE VISUAL INSPECTION THE CUT BLOCK WAS FOUND NOT TO BE DAMAGED, NO DAMAGE OR BROKEN PARTS WERE DETECTED, HOWEVER, DAMAGE IN THE PROTECTIVE SHEATH WAS FOUND. THIS DAMAGE WAS REVIEWED UNDER MAGNIFICATION AND NOTICED THAT THE SHAPE MATCHES WITH THE PARTICLE THAT WAS SENT. FUNCTIONAL TESTING WAS NOT CONDUCTED. AS ADDITIONAL INFORMATION, THE PARTICLE WAS CHEMICALLY ANALYZED AND ACCORDING TO THE ANALYSIS RECORDS PROVIDED, THE PARTICLE MATCHES WITH THE COMPOSITION THAT THE PROTECTIVE SHEATH IS MADE. THE COMPLAINT WAS CONFIRMED, AND ROOT CAUSE ANALYSIS DETERMINED THAT THE FAILURE WAS ATTRIBUTABLE TO FOREIGN MATERIAL COMING FROM THE PROTECTIVE SHEATH. THIS ISSUE WAS MOST PROBABLY RELATED TO USER ERROR AND/OR CUSTOMER TECHNIQUE REGARDING WARNINGS AND PRECAUTIONS SECTION OF THE IFU QUOTES ¿AVOID OPERATOR OR INSTRUMENT CONTACT WITH THE SHEATHED NEEDLE PORTION OF THE ATEC BREAST BIOPSY DEVICE¿ AND ¿THE BIOPSY PROCEDURE SHOULD BE PERFORMED ONLY BY PERSONS HAVING ADEQUATE TRAINING AND FAMILIARITY WITH THIS PROCEDURE¿. CONCLUSION: THE REPORTED ISSUES HAVE BEEN CONFIRMED, AND THE MOST PROBABLE ROOT CAUSE HAS BEEN IDENTIFIED. A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING DEVICE HISTORY RECORDS, COMPLAINT DATA, AND RISK ASSESSMENTS. THE INVESTIGATION SUGGESTS THIS IS NOT A RECURRING ISSUE WITHIN THE PRODUCT FAMILY, SYSTEM, OR FAILURE MODE REFERENCED IN THE COMPLAINT. CAPA/HRA/NCR/SCAR ARE NOT DEEMED REQUIRED AT THIS MOMENT BY THIS EVENT. FUTURE EVENTS WILL BE MONITORED AND TRENDED. DEVICE HISTORY RECORD (DHR) REVIEW: THE DHR WAS REVIEWED FOR THE CORRESPONDING LOT, AND NO RELEVANT RISK FACTORS WERE FOUND IN THE MANUFACTURING PROCESS. LOT NUMBER E23K27RA. EXPIRATION DATE 26-OCT-2025. MANUFACTURE DATE 27-OCT-2023. UDI (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INVESTIGATION INFORMATION: AN INVESTIGATION WAS CONDUCTED: IT WAS REPORTED THAT ON (B)(6) 2024, A PHYSICIAN REPORTED THAT SOMETIMES WHEN PERFORMING A BIOPSY WITH AN ATEC NEEDLE THEY NOTICED A PIECE OF MATERIAL PLASTIC IN BETWEEN THE SPECIMENS. PHYSICIAN PROVIDED A PICTURE IN WHICH IT CAN BE OBSERVED A PLASTIC PARTICLE MIXED ALONG WITH THE SAMPLES. THE PARTICLES WERE ONLY OBSERVED IN THE SAMPLES AND NOT IN THE PATIENTS. NO SAMPLES HAVE BEEN OBSERVED IN THE BREAST OF THE PATIENT. PHYSICIAN REPORTED THAT NO INJURY WAS REPORTED TO PATIENTS NOR USERS. THE DEVICE WAS RETURNED TO THE POST MARKET QUALITY LABORATORY FOR INVESTIGATION. VISUAL INSPECTION WAS CONDUCTED, AND THE COMPLAINANT SENT A BOTTLE WITH A SAMPLE THAT LOOKS LIKE A PLASTIC PIECE, AS EVIDENCE OF THE FOREIGN MATERIAL. DURING THE VISUAL INSPECTION THE CUT BLOCK WAS FOUND NOT TO BE DAMAGED, NO DAMAGE OR BROKEN PARTS WERE DETECTED, HOWEVER, DAMAGE IN THE PROTECTIVE SHEATH WAS FOUND. THIS DAMAGE WAS REVIEWED UNDER MAGNIFICATION AND NOTICED THAT THE SHAPE MATCHES WITH THE PARTICLE THAT WAS SENT. FUNCTIONAL TESTING WAS NOT CONDUCTED. AS ADDITIONAL INFORMATION, THE PARTICLE WAS CHEMICALLY ANALYZED AND ACCORDING TO THE ANALYSIS RECORDS PROVIDED, THE PARTICLE MATCHES WITH THE COMPOSITION OF THE PROTECTIVE SHEATH. THE COMPLAINT WAS CONFIRMED, AND ROOT CAUSE ANALYSIS DETERMINED THAT THE FAILURE WAS ATTRIBUTABLE TO FOREIGN MATERIAL COMING FROM THE PROTECTIVE SHEATH. A REPLICATION WAS PERFORMED, AND IT WAS ESTABLISHED THAT THE ISSUE IS MOST LIKELY DUE TO INCORRECT REMOVAL OF THE PROTECTIVE SHEATH FROM THE DEVICE CANNULA, WHICH RESULTS IN SHAVING THE TIP OF THE SHEATH. THIS ISSUE WAS MOST PROBABLY RELATED TO USER ERROR AND/OR CUSTOMER TECHNIQUE. WARNINGS AND PRECAUTIONS SECTION OF THE IFU INDICATES ¿AVOID OPERATOR OR INSTRUMENT CONTACT WITH THE SHEATHED NEEDLE PORTION OF THE ATEC BREAST BIOPSY DEVICE¿ AND ¿THE BIOPSY PROCEDURE SHOULD BE PERFORMED ONLY BY PERSONS HAVING ADEQUATE TRAINING AND FAMILIARITY WITH THIS PROCEDURE¿. THE INVESTIGATION INVOLVED A COMPREHENSIVE REVIEW OF DEVICE HISTORY RECORDS, IFU, COMPLAINT DATA, RISK ASSESSMENTS, AND TESTING RESULTS. CONCLUSION: THE REPORTED ISSUES HAVE BEEN CONFIRMED, AND THE MOST PROBABLE ROOT CAUSE HAS BEEN IDENTIFIED. A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING DEVICE HISTORY RECORDS, COMPLAINT DATA, AND RISK ASSESSMENTS. NO NEW CAPA, HRA, NCR, OR SCAR ARE DEEMED REQUIRED AT THIS MOMENT BASED ON THIS EVENT FUTURE EVENTS WILL BE MONITORED AND TRENDED. COMPLAINT CONFIRMED: YES. DEVICE HISTORY RECORD (DHR) REVIEW: THE DHR WAS REVIEWED FOR THE CORRESPONDING LOT, AND NO RELEVANT RISK FACTORS WERE FOUND IN THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT/SERIAL NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024 A PHYSICIAN REPORTED THAT SOMETIMES WHEN PERFORMING A BIOPSY WITH AN ATEC NEEDLE THEY NOTICED A PIECE OF MATERIAL PLASTIC IN BETWEEN THE SPECIMENS. PHYSICIAN PROVIDED A PICTURE IN WHICH IT CAN BE OBSERVED A PLASTIC PARTICLE MIXED ALONG WITH THE SAMPLES. THE PARTICLES WERE ONLY OBSERVED IN THE SAMPLES AND NOT IN THE PATIENTS. NO SAMPLES HAVE BEEN OBSERVED IN THE BREAST OF THE PATIENT. PHYSICIAN REPORTED THAT NO INJURY WAS REPORTED TO PATIENTS NOR USERS. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614352 ATEC 0912-12 INSTRUMENT, BIOPSY KNW HOLOGIC, INC ATEC 0912-12 E23K27RA 15420045504851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown