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 Codes	Loss of consciousness (2418); Movement Disorder (4412)
Date of Event	09/19/2025
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.
Event or Problem Description
It was reported by the user site that ten minutes after a brevera breast biopsy procedure on (b)(6) 2025, the patient briefly lost consciousness, which was followed by confused speech and involuntary movements of the head and limbs.It is further reported by the user site that emergency services were called, the patient's heart rate was elevated and she vomited; however, blood pressure, oxygen saturation, respiratory rate and blood glucose levels were normal throughout.It is reported that the patient does not have any known allergies and no swelling of the face was observed.The user site reports that the patient improved while awaiting emergency services to arrive, but the involuntary movements of the right arm persisted.The user site reports that the patient provided an update that the remaining symptom resolved and that the ct brain scan was normal; however, the patient was awaiting further neurological assessment.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: 23302591
• Report Number: 1222780-2025-00536
• Device Sequence Number: 13250035
• Product Code: KNW
• UDI-Device Identifier: 15420045512863
• UDI-Public: (01)15420045512863(17)261030(10)24K30R
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

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: 24K30R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2024
• 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