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

Model Number	BREVDISP09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a brevera breast biopsy procedure on (b)(6) 2025, post procedure images revealed "new scattered unknown artifacts." it is reported that the patient was referred to a breast surgeon for excision of the area, which was completed on an unknown date.Multiple good faith efforts to obtain additional information from the user site were unsuccessful.No further information is currently available.
Additional Manufacturer Narrative
Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that after a brevera breast biopsy procedure on (b)(6) 2025, post procedure images revealed "new scattered unknown artifacts." it is reported that the patient was referred to a breast surgeon for excision of the area, which was completed on an unknown date.Multiple good faith efforts to obtain additional information from the user site were unsuccessful.Initial evaluation: the device was not available for return; visual and functional analysis/testing could not be conducted for the event described.Investigation methods and findings: the sample was not returned for this complaint and there was limited patient-related information provided for this event; therefore, a thorough investigation was not able to be performed.Cause/root cause: a confirmation of the brevera disposable causing the harm could not be done.Conclusion: the issue could not be confirmed since the device was not available for further investigation.The cause of the complaint could not be established with the available evidence.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: the user site was unable to provide the device lot number and the device is not available for return to the manufacturer for further investigation.No further information is currently available.

• 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: 24569758
• Report Number: 1222780-2026-00111
• Device Sequence Number: 20928851
• Product Code: KNW
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 06/08/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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