MAUDE Adverse Event Report: HOLOGIC, INC ATEC 1212-20; INSTRUMENT, BIOPSY

Model Number	ATEC 1212-20
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an atec procedure on (b)(6) 2025, the user tested the needle, completed the biopsy and observed the tissue samples in the filter while performing the lavage; however, the user reports that upon attempting to obtain the tissue from the filter, it was not present.The user reports that a second procedure was required to obtain additional tissue samples as the initial tissue samples were never found.No further information is currently available.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that during an atec procedure on (b)(6) 2025, the user tested the needle, completed the biopsy and observed the tissue samples in the filter while performing the lavage; however, the user reports that upon attempting to obtain the tissue from the filter, it was not present.The user reports that a second procedure was required to obtain additional tissue samples as the initial tissue samples were never found.Functional testing could not be performed due to the condition of the returned unit, which exhibited significant damage: the tubing was cut, and the outer cannula had been removed.Root cause analysis did not identify a definitive root cause.The investigation included a comprehensive review of device history records, complaint data, risk assessment, and testing results.No single failure mode or specific fault could be conclusively linked to the event.However, based on the findings of the clinical investigation, the complaint is confirmed.Conclusion: the root cause analysis did not identify a definitive cause.A thorough review of device history records, complaint data, risk assessments, and testing did not reveal a specific failure mode.The risk trending calculations results do not increase the risk index zone.No further actions are required at this moment.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.

• Brand Name: ATEC 1212-20
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 22966635
• Report Number: 1222780-2025-00481
• Device Sequence Number: 9257292
• Product Code: KNW
• UDI-Device Identifier: 15420045504912
• UDI-Public: (01)15420045504912(17)270224(10)E25B24RC
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ATEC 1212-20
• Device Catalogue Number: ATEC 1212-20
• Device Lot Number: E25B24RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown