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 Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
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.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.Medsun/medwatch report received (b)(4).
Event or Problem Description
It was reported that during a brevera breast biopsy procedure on (b)(6) 2025, the device made and abnormal sound.It is reported that the device took the samples as expected; however, during post procedure imaging, the user observed apparent metallic fragments in the patient's breast.The user reports that upon inspection of the device, it does not look right.It is reported that the procedure was completed; however, the user is unable to confirm if the calcifications were retrieved.No medical intervention was required at the time of the biopsy.A field service engineer (fse) was dispatched to examine the brevera console and found there were no error codes, and the issue appeared to be related to an apparent disposable needle failure.The fse reviewed post procedure images, which appeared to show a metallic object behind the clip.The fse evaluated the brevera console and reports that all tests were good.Additionally, it was reported that all needles in the associated lot were removed from use.No further information is currently available.Medsun/medwatch report received (b)(4).
Additional Manufacturer Narrative
An investigation was conducted: it was reported that during a brevera breast biopsy procedure on (b)(6) 2025, the device made an abnormal sound.It is reported that the device took the samples as expected; however, during post procedure imaging, the user observed apparent metallic fragments in the patient's breast.The user reports that upon inspection of the device, it does not look right.It is reported that the procedure was completed; however, the user is unable to confirm if the calcifications were retrieved.No medical intervention was required at the time of the biopsy.A field service engineer (fse) was dispatched to examine the brevera console and found there were no error codes, and the issue appeared to be related to an apparent disposable needle failure.The fse reviewed post procedure images, which appeared to show a metallic object behind the clip.The fse evaluated the brevera console and reports that all tests were good.Additionally, it was reported that all needles in the associated lot were removed from use.No further information is currently available.The device was returned to the post market quality laboratory for investigation.Visual inspection was conducted and there were signs of physical damage.During the inspection, damage to the inner cannula tip was found.As additional information, the bearing gears were damaged, and the tubing was cut.Functional testing was not conducted due to the damage that the device presents.Functional testing was not conducted due to the damage that the device presents, the issue can be confirmed visually, and no additional test is needed.The complaint was confirmed, and root cause analysis determined that the failure was attributable to damage to the tip of the inner cannula and inner diameter of the outer cannula with marks.The failure mode was associated with an over-advanced inner cannula (ic), likely caused by excessive and extreme interaction between the cannulas.This occurs because the inner cannula undergoes greater displacement during its translational motion.Such extreme conditions can lead to multiple failure modes that compromise the integrity of the cannulas.This complaint and the root cause are related to an already established capa.Conclusion: the reported issues have been confirmed, and the most probable root cause has been identified.A comprehensive review was conducted, including device history records, complaint data, and risk assessments.A capa has already been created to establish the need for updates to the risk management files and corresponding corrective and preventive actions regarding the specific damage between the outer and inner cannula.This capa covered the failure mode but is still in the implementation/execution phase.A health risk assessment was created to address this issue, and the corresponding updates to the risk management files have already been implemented.Future events will be monitored and trended.Device history record (dhr) review: the dhr was reviewed for the corresponding lot, and the device was released meeting all qa specifications.Medsun/medwatch report received (b)(4).

• 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: 22894700
• Report Number: 1222780-2025-00455
• Device Sequence Number: 12985826
• Product Code: KNW
• UDI-Device Identifier: 15420045512863
• UDI-Public: (01)15420045512863(17)270222(10)25B22RC
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/08/2025

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: 25B22RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2025
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American