MAUDE Adverse Event Report: HOLOGIC, INC ATEC 0912-20; INSTRUMENT, BIOPSY

Model Number	ATEC 0912-20
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.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.
Event or Problem Description
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.
Additional Manufacturer Narrative
An investigation was conducted: a physician reported that sometimes when performing a biopsy with an atec needle they noticed a piece of material plastic in between the specimens.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 and that the procedure was completed with the same device.No other information available.The device was not returned to the post market quality laboratory for investigation.Visual and functional inspection could not be conducted.Functional test was not conducted, the damage reported was foreign material and the functional test is not necessary to confirm the issue reported.Root cause analysis did not identify the most probable root cause.The investigation included a comprehensive review of device history records, complaint data, risk assessments, and visual testing results.Biocompatibility testing on the atec disposable device, where the protective sheath components were tested and proved as safe meaning that no potential adverse reactions or harms are expected in the patients after the normal use of the atec device.Additionally, atec breast biopsy device instructions for use (ifu), contains in the warnings and precautions section the following statement regarding sheathed portion of the needle ¿avoid operator or instrument contact with the sheathed needle portion of the atec breast biopsy device¿.Additionally, on the same page the ifu specifies the following regarding the use of product: ¿the biopsy procedure should be performed only by persons having adequate training and familiarity with this procedure¿.Both of those statements reflect need of the right technique and support the operator in an appropriate use of the device trained to avoid damage to the protective sheath during the removal of it.Conclusion: the reported issue has not been confirmed.A comprehensive review was conducted, including device history records, complaint data, and risk assessments.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 not reviewed because the lot number was not available.

• Brand Name: ATEC 0912-20
• 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: daniel guevara ; coyol free park zone b24; alajuela 20102
• MDR Report Key: 21261345
• Report Number: 1222780-2025-00041
• Device Sequence Number: 9373258
• Product Code: KNW
• UDI-Device Identifier: 15420045504868
• UDI-Public: 15420045504868
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ATEC 0912-20
• Device Catalogue Number: ATEC 0912-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown