BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATEC 0909-20

    MDR report key: 21385713 · Received February 14, 2025

    Report

    Report Number
    1222780-2025-00077
    Event Type
    Injury
    Date Received
    February 14, 2025
    Date of Event
    January 14, 2025
    Report Date
    September 24, 2025
    Manufacturer
    HOLOGIC, INC
    Product Code
    KNW
    PMA / PMN Number
    K042290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED: IT WAS REPORTED THAT AN ATEC DISPOSABLE DEVICE. ¿WENT DULL MIDWAY¿. THERE WAS NO HARM TO THE PATIENT, AND THE PROCEDURE WAS ABORTED. THE DEVICE RETURNED TO THE POST MARKET QUALITY LABORATORY FOR INVESTIGATION. VISUAL INSPECTION WAS CONDUCTED, AND THERE WERE SIGNS OF PHYSICAL DAMAGE, THE DEVICE ARRIVED WITHOUT THE CANNULA, FUNCTIONAL INSPECTION WAS NOT PERFORMED. ROOT CAUSE ANALYSIS DID NOT IDENTIFY A DEFINITIVE ROOT CAUSE. THE INVESTIGATION INCLUDED A COMPREHENSIVE REVIEW OF DEVICE HISTORY RECORDS, COMPLAINT DATA, RISK ASSESSMENTS, AND VISUAL TESTING RESULTS. DESPITE THESE EFFORTS, NO SINGLE FAILURE MODE OR SPECIFIC FAULT COULD BE CONCLUSIVELY LINKED TO THE EVENT. THERE WAS INSUFFICIENT INFORMATION TO ESTABLISH CAUSALITY. QUALITY INSPECTION PROCESSES ARE NOT IMPLEMENTED AT THE PRODUCTION LINE TO PREVENT THE RECURRENCE OF SIMILAR EVENTS, REGARDING ¿TISSUE ACQUISITION ISSUE¿, HOWEVER, THERE ARE PROCEDURES TO ENSURE COMPLIANCE WITH ESTABLISHED STANDARDS OF THE DEVICE FUNCTIONING AS INTENDED. BASED ON ALL THE INFORMATION PRESENTED, IT IS NOT ENOUGH INFORMATION TO DETERMINE IF THIS CASE IS MOST LIKELY AN UNUSUAL OCCURRENCE. CONCLUSION: THE REPORTED ISSUE HAS BEEN CONFIRMED. ROOT CAUSE ANALYSIS DID NOT IDENTIFY A DEFINITIVE ROOT CAUSE; ONLY CONTRIBUTING FACTORS WERE FOUND TO BE ASSOCIATED WITH THE REPORTED EVENT. THE INVESTIGATION INCLUDED A COMPREHENSIVE REVIEW OF DEVICE HISTORY RECORDS, COMPLAINT DATA, RISK ASSESSMENTS AND VISUAL TESTING RESULTS. DESPITE THESE EFFORTS, NO SINGLE FAILURE MODE OR SPECIFIC FAULT COULD BE CONCLUSIVELY LINKED TO THE EVENT. THERE WAS NOT ENOUGH INFORMATION TO ESTABLISH CAUSALITY. THE RISK INDEX FOR THIS SITUATION IS WITHIN THE RANGE ALREADY CALCULATED IN THE RISK TRENDING, IT IS PROBABLE THAT THIS IS AN ISOLATED ISSUE AND NOT A RECURRING PROBLEM WITHIN THE PRODUCT FAMILY, SYSTEM, OR FAILURE MODE REPORTED IN THE COMPLAINT; THEREFORE, NO UPDATE OF THE RISK MANAGEMENT FILE IS REQUIRED. A CAPA IS NOT REQUIRED BECAUSE OF THIS COMPLAINT. AS PER THE DHR REVIEW, THE FUNCTIONALITY OF THE DEVICES FROM THE LOT IS VERIFIED DURING LINE QUALITY INSPECTIONS. THIS EVENT WAS DETERMINED TO BE AN ISOLATED CASE AND NOT INDICATIVE OF A SYSTEMIC ISSUE. FUTURE EVENTS WILL BE MONITORED AND TRENDED. DEVICE HISTORY RECORD (DHR) REVIEW: THE DHR WAS REVIEWED FOR THE CORRESPONDING LOT; HOWEVER, NO RELEVANT RISK FACTORS WERE FOUND IN THE MANUFACTURING PROCESS. LOT NUMBER: E24F27RM, EXPIRATION DATE: 27-JUN-2026, MANUFACTURE DATE: 27-JUN-2024, UDI: (B)(4).

    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 DURING AN ATEC PROCEDURE ON (B)(6) 2025, THE NEEDLE WENT DULL MIDWAY PROCEDURE. THE PROCEDURE COULD NOT BE COMPLETED AND THE PATIENT RESCHEDULED. NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002334 ATEC 0909-20 INSTRUMENT, BIOPSY KNW HOLOGIC, INC ATEC 0909-20 E24F27RM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other