MAUDE Adverse Event Report: HOLOGIC, INC BREVERA BREAST BIOPSY SYSTEM; INSTRUMENT, BIOPSY

Model Number	BREVDISP09
Medical Device Problem Codes	Structural Problem (2506); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that during a brevera breast biopsy procedure on (b)(6) 2025, the user observed that the introducer extended to the tip of the needle and observed "right breast buckling with skin nick." additional information was obtained from the user site, and it was reported that the procedure was successfully completed with another device; however, the radiologist performing the procedure had to use a scalpel, multiple needles and made a second incision to the patient's breast.No further information is currently available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that during a brevera breast biopsy procedure on (b)(6) 2025, the user observed that the introducer extended to the tip of the needle and observed "right breast buckling with skin nick." additional information was obtained from the user site, and it was reported that the procedure was successfully completed with another device; however, the radiologist performing the procedure had to use a scalpel, multiple needles and made a second incision to the patient's breast.No further information is currently available.The device was not available for return; visual and functional analysis/testing could not be conducted for the event described.The device was not returned for this complaint, and only limited patient-related information was provided, however, even though a full visual or functional investigation could not be conducted, it is possible to associate current issues with an existing issue regarding 25e28rc lot number.Cause/root cause: the investigation determined that the most probable root cause of the device failure consists of the introducer length.The investigation involved a comprehensive review of device history records, complaint data, risk assessments, and testing results.Incoming inspection processes are implemented in the production process to ensure compliance with established standards.However, at the time this device was manufactured, there was no control points placed at the production line to prevent recurrence of similar events and to ensure compliance with established standards.A capa was initiated in (b)(6) 2025 following the escalation of a non-conformance event to document and implement corrective actions for the impacted lots (including 25e28rc) of brevdisp09 (brevera® breast biopsy system disposable 9 gauge needle).Conclusion: the reported issues have been confirmed, and the most probable root cause has been identified.A comprehensive review was conducted, including device history records, complaint data, and risk assessments.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: BREVERA BREAST BIOPSY SYSTEM
• 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: 22956912
• Report Number: 1222780-2025-00476
• Device Sequence Number: 12826981
• Product Code: KNW
• UDI-Device Identifier: 15420045512863
• UDI-Public: (01)15420045512863(17)270528(10)25E28RC
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K163052
• 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): 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: BREVDISP09
• Device Catalogue Number: BREVDISP09
• Device Lot Number: 25E28RC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2025
• 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