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	Hematoma (1884)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an atec biopsy procedure on (b)(6) 2025, saline flow and sampling issues were experienced.The user reports that the device pre-procedure set-up and testing were okay but more saline than usual was observed dripping out of the end of the needle when it was lifted to be inserted into the patient's breast.The user further reports that six cores were completed and x-rayed but no calcification was observed.The user reports that another six cores were obtained with no calcification observed and again another six cores, still with no calcification.The user reports that after eighteen cores, the patient was bleeding and the user site observed that the saline bag was all emptied into the waste bottle.It is reported that the biopsy was unsuccessful, the patient experienced a hematoma and had to be rescheduled for another biopsy procedure.No further information is currently available.
Additional Manufacturer Narrative
Hologic is submitting this report in accordance with 21.Cfr part 803.The submission is based upon the currently available information.The submission of this report does not represent a confirmation of device malfunction involving the hologic products in the event described.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 biopsy procedure on (b)(6) 2025, saline flow and sampling issues were experienced.The user reports that the device pre-procedure set-up and testing were okay but more saline than usual was observed dripping out of the end of the needle when it was lifted to be inserted into the patient's breast.The user further reports that six cores were completed and x-rayed but no calcification was observed.The user reports that another six cores were obtained with no calcification observed and again another six cores, still with no calcification.The user reports that after eighteen cores, the patient was bleeding and the user site observed that the saline bag was all emptied into the waste bottle.It is reported that the biopsy was unsuccessful, and there was harm to the patient, the patient experienced a hematoma and had to be rescheduled for another biopsy procedure.The device was not available for return; visual and functional analysis/testing could not be conducted for the described event the device was not returned for this complaint, and only limited patient-related information was provided.Therefore, a full investigation could not be conducted.Without the returned sample, it is not possible to confirm a definitive root cause of the issue.Root cause analysis did not identify a definitive root cause.The investigation included a comprehensive review of complaint data and risk assessments, but could not perform any testing procedures, because the device was not returned.Conclusion: the reported issue could not be confirmed because the device was not returned.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 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: 23057240
• Report Number: 1222780-2025-00496
• Device Sequence Number: 9226148
• Product Code: KNW
• UDI-Device Identifier: 15420045504912
• UDI-Public: (01)15420045504912(17)270114(10)E25A14RB
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 12/08/2025

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: E25A14RB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2025
• 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