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	11/04/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported by the user site that during a brevera breast biopsy procedure on (b)(6) 2025, "imaging system error" and "no filter found" errors were observed.It is reported that the needle was fired into the patient's breast in preparation to obtain samples; however, when the radiologist attempted to obtain the first sample, the system displayed the "no filter found" error.The user reports that troubleshooting was attempted by opening and closing the system drawer and changing the filter, but the procedure could not be completed.The user reports that the needle was removed from the patient and the procedure was rescheduled.A hologic field service engineer (fse) was dispatched to examine the device and in conjunction with hologic remote technical support, was able to clear the "no filter found" error by reloading code to the device.Despite clearing the error, the fse reports that the filter chambers were misaligned when imaging.The fse completed tray alignment and motor accuracy tests, but this did not completely resolve the misalignment.The fse provided the user site with information regarding corlumina replacement as well as entire device replacement.The user site is pending a final decision on how they prefer to move forward with repair.No further information is currently available.
Additional Manufacturer Narrative
Correction regarding device history record (dhr) review: a device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.
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, filter not found and imaging system error, respectively.The customer reported that after setting up a patient for a procedure, the system began displaying these errors and would not allow the biopsy to proceed.The procedure was aborted.Patient impact was reported since the procedure was aborted after the needle was inserted.Remote technical support was able to clear the filter errors by reloading the csl code, but afterwards, the filter chambers were not aligned with the image window.After performing filter alignment and motor tests, the filter was still misaligned.The corlumina unit was replaced, and the console was returned to the customer for use.Initial evaluation: no parts were returned to hologic pmqa for evaluation.The system had been in use for approximately 1 year and 2 months at the time of the complaint, based on the difference between the install date and the incident date for the complaint.Investigation methods and findings: since no parts were returned to hologic pmqa, no investigation could be carried out.Cause/root cause: since no investigation could be carried out, a definitive root cause could not be determined.Based on the details of the complaint, as well as actions taken by tech support to resolve the issue, there are likely two probable root causes.One is an issue with the (b)(4) recognizing the filter and properly aligning it with the x-ray imager, and another with the hall effect sensor detecting the tissue filter.Conclusion: the failure mode described in the complaint could not be confirmed as no parts were returned to hologic pmqa for investigation.As a result, no definitive root cause could be determined.Based on the details of the complaint, as well as the observations and steps taken by tech support to resolve the issue, there are two probable root causes.One is an issue with the hall effect sensor in the corlumina system and the other is an issue with the motor control in the drawer module.The issue was resolved by replacing the corlumina unit.Patient impact was reported as the procedure was aborted after the needle was inserted into the patient.The calculated risk index for these issues is within the ¿acceptable¿ zone, and in line with the risk index.Complaints will continue to be monitored and trended.Complaint confirmed: no device history record (dhr) review: system sku: brev100 system serial number: (b)(6) system manufacture date: 2/6/2024 system installation date: 9/6/2024 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: 23572284
• Report Number: 1222780-2025-00588
• Device Sequence Number: 21375559
• Product Code: KNW
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 05/18/2026

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: 11/04/2025
• Supplement Date Received by Manufacturer: Not provided; 04/23/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 11/18/2025; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2024
• 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