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

Model Number	BREV100
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, during a brevera procedure, an error displayed on the brevera device after the needle had been inserted into the patient.The customer was unable to clear the displayed error, and the system would not image or acquire tissue.The procedure was stopped and the patient was rescheduled, which will require a new incision.No further information is 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.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: brief description: it was reported on (b)(6) 2025 that during a procedure the brevera system (b)(6) began experiencing errors related to the filter cartridge and the system could no longer take images.The biopsy was stopped and the patient was rescheduled.The tech support representative was able to speak to the customer and learned that after switching to a new lot of disposables, the issue cleared, leading them to believe the issue was with the lot of disposables used.Initial evaluation: no parts were returned to hologic for initial evaluation.The system was in use for 28 months at the time of the complaint.Investigation methods and findings: none of the equipment used in the complaint was returned.As a result, no investigation could be performed.Cause/root cause: since no investigation could be performed, a definitive root cause could not be determined.In the case notes, the tech support personnel assigned to the case states that once the customer switched to a new lot of needles, they no longer had issues, indicating that the cause was the disposable itself.Based on this, the most probable root cause is a bad sensing magnet in the tissue filter tray preventing it from being recognized by the system.Conclusion: none of the equipment used in the complaint was returned for investigation.As a result, no issues could be confirmed, and a definitive root cause could not be determined.The tech support representative noted that the customer stated that after switching to a new lot of disposables, the issues were not experienced, indicating that the most likely root cause was an issue with that lot of disposables.Complaint confirmed: no device history record (dhr) review: system sku: (b)(4) system serial number: (b)(6) system manufacture date: 2/24/2022 system installation date: (b)(6) 2023 udi: (b)(4).The device history record for the serial number involved was reviewed and was found to have met all manufacturing requirements prior to shipment for distribution.This includes final inspection and packaging inspections.

• 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: 22171400
• Report Number: 1222780-2025-00322
• Device Sequence Number: 9218453
• Product Code: KNW
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 05/28/2026

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: BREV100
• Device Catalogue Number: BREV100
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown