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	04/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, during an atec procedure, the atec needle was not suctioning.The customer reports that no samples were pulled into the tissue filter and one small sample was in the aperture.As a result, the procedure could not be completed.No additional information is 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
It was reported that for a atec disposable device that ¿the atec needle was not suctioning.No samples were pulled into the tissue filter.One small sample was in the aperture.¿ there was no harm to the patient.The procedure was aborted.The equipment/device was not available for return; visual and functional analysis/testing could not be conducted for the event described.A trend review has been completed, showing no recent significant spikes or adverse patterns related to this issue.Root cause analysis did not identify a definitive root cause.The investigation included a comprehensive review of device history records, complaint data, risk assessments, but could not perform any testing procedures, because the devices were not returned.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, and to be able to perform as intended and retrieve cores without any issues.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 is confirmed.Root cause analysis did not identify a definitive root cause; only contributing factors prolonged procedure - no additional risk to patient were found to be associated with the reported event, according to the complaint record there was no harm to the patient.Regarding the atec needle that was not suctioning, the root cause could not be determined because of lack of evidence and information.Only contributing factors were found to be associated with the reported event.It is important to note that the affected device was not returned; therefore, visual and functional testing could not be conducted.As a result, there was insufficient information to determine the most probable cause of the not suctioning issue.The investigation included a comprehensive review of device history records, complaint data, risk assessments, regarding this information this issue is most probably an unusual occurrence, functional and visual testing could not be performed.Despite these efforts, no single failure mode or specific fault could be conclusively linked to the event.Some factors may have increased the likelihood of occurrence but were insufficient to establish causality.Future events will be closely monitored and analyzed for potential trends.This event was determined to be an isolated case and not indicative of a systemic issue and does not require a capa because of this complaint.A health risk assessment (hra) is not required based on the evaluation of the investigation and associated risk analysis.Device history record (dhr) review: the dhr was reviewed for the corresponding lot; however, 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: 22061366
• Report Number: 1222780-2025-00270
• Device Sequence Number: 12672382
• Product Code: KNW
• UDI-Device Identifier: 15420045504912
• UDI-Public: (01)15420045504912(17)261220(10)E24M20RM
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/16/2025

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: E24M20RM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2024
• 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