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

Model Number	ATEC 0912-20
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an atec procedure on (b)(6) 2024, the physician reported that pieces of plastic remained behind in the breast of the patient.No other information could be obtained.
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
Additional information received from the physician, the event did not occur and no fragments were observed in the breast.Thus, this event has been assessed as not reportable.

• 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 ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 21035403
• Report Number: 1222780-2024-00505
• Device Sequence Number: 9133107
• Product Code: KNW
• UDI-Device Identifier: 15420045504868
• UDI-Public: (01)15420045504868(17)260610(10)E24F10RF
• 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): 02/25/2025

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 Expiration Date: 06/10/2026
• Device Model Number: ATEC 0912-20
• Device Catalogue Number: ATEC 0912-20
• Device Lot Number: E24F10RF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2024
• 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