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

Model Number	BREVDISP09
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number of the device was 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.
Event or Problem Description
It was reported by the user site that "particles [were] left in [a] patient's breast during [a brevera] biopsy procedure on (b)(6) 2025." additional information was obtained from the user, and it is reported that after multiple attempts at sampling and adjusting the device, the calcifications would not pull into the trough.It is further reported that because the targeted calcifications could not be well sampled and the "artifact seen in the breast after biopsy was of unknown etiology," an "excisional biopsy was necessary to fully remove the originally targeted calcifications and also served to remove the surrounding artifacts." it is reported that the originally targeted calcifications were benign according to the pathology; however, the pathologist "could not provide any additional diagnostic information about the specimen and noted that there is no clear literature to provide guidance in clearly identifying such foreign material." it is reported that the patient is asymptomatic and "there is minimal residual (2mm of artifact) seen confined to the skin in the region of the excision scar." 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: 25174384
• Report Number: 1222780-2026-00280
• Device Sequence Number: 21463666
• Product Code: KNW
• UDI-Device Identifier: 15420045512863
• UDI-Public: 15420045512863
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/14/2026
• 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