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	05/19/2025
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.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.
Event or Problem Description
It was reported that on (b)(6) 2025, during a vacuum assisted biopsy procedure using a brevera device, the user heard a grinding sound and stopped the procedure.The user reports that the system was flushed, put in standby and with some minor resistance, the needle was removed from the patient.It is reported that the marker clip was placed, and the plastic introducer sheath was damaged but intact.Additionally, the user reports that the post procedure clip views revealed a metallic foreign body that was not in previous imaging.The user reports that upon inspection of the needle, the distal portion of the cutter was fractured, and a portion was missing.No further information is currently available.
Additional Manufacturer Narrative
An investigation was completed: it was reported that on (b)(6) 2025, during a vacuum assisted biopsy procedure using a brevera device, the user heard a grinding sound and stopped the procedure.The user reports that the system was flushed, put in standby and with some minor resistance, the needle was removed from the patient.It is reported that the marker clip was placed, and the plastic introducer sheath was damaged but intact.Additionally, the user reports that the post procedure clip views revealed a metallic foreign body that was not in previous imaging.The user reports that upon inspection of the needle, the distal portion of the cutter was fractured, and a portion was missing.The device was returned to the post market quality laboratory for investigation.Visual inspection was conducted.The device was received with the tubing cut.Also, the tip of the inner cannula, the cut block and the edge of the window of the outer cannula were found damaged.As additional information, the bearing and gears were inspected, and no issues were found, functional testing was not conducted due to damage to the device.As additional information from the physician ¿the procedure went okay; they were able to obtain 2 samples, but on the 3rd one, the device malfunction did occur.No problem with the patient.In the 2 samples obtained, calcs were found and it was benign.The metal fragment was surgically removed on (b)(6) 2025, without any issue or complications.¿ after communicating with the customer, it was known that in this case, the patient had multiple titanium breast cancer surgery clips from previous surgery that were placed close to the targeted biopsy site.It was reasonably suggested that one of the clips may have fallen into the aperture of the device, so that the inner cannula of brevera device may have directly hit with the titanium clip when being fired, resulting in most probable cause of damage and even breakage of the brevera needle.Root cause analysis did identify a most probable root cause; based on the provided images and x-rays, all the information provided by the physician and the patient, and analysis of the returned device, the damages were most probably caused by the presence of titanium made clips in the biopsied area, it is probable that the device did hit one or more clips and this/these did damage the cannula, leading to a broken metal particle ending in the patient's breast.This scenario highlights the importance of accounting for surgical clips or other metallic implants during pre-procedure planning.Radiologists or clinicians need to carefully evaluate imaging and device placement to minimize risks to both the patient and the equipment.There are no quality inspection processes implemented at the production line to prevent the recurrence of similar events.Based on all the information presented, it is most likely that this was an unusual occurrence.Conclusion: root cause analysis did identify a most probable root cause; based on the provided images and x-rays, all the information provided by the physician and the patient, and analysis of the returned device, the damages were most probably caused by the presence of titanium made clips in the biopsied area, it is probable that the device did hit one or more clips and this/these did damage the cannula, leading to a broken metal particle ending in the patient's breast.This event did not trigger escalation to nce, capa, hra or scar due to the following reasons: there was harm to patient, but use error was found to be the potential hazard, this scenario highlights the importance of accounting for surgical clips or other metallic implants during pre-procedure planning.Radiologists or clinicians need to carefully evaluate imaging and device placement to minimize risks to both the patient and the equipment.Based on all the information presented, it is most likely that this was an unusual occurrence and there is no evidence of a systemic issue at the moment this complaint was reported.Device history record (dhr) review: the dhr was reviewed for the corresponding lot, and no relevant risk factors were found in the manufacturing process.Lot number 24j02r expiration date 09/02/2026 manufacture date 09/02/2024 udi (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: 22212048
• Report Number: 1222780-2025-00327
• Device Sequence Number: 8620324
• Product Code: KNW
• UDI-Device Identifier: 15420045512863
• UDI-Public: (01)15420045512863(17)260902(10)24J02R
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,Followup
• Report Date (Section B): 09/23/2025

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 Expiration Date: 09/02/2026
• Device Model Number: BREVDISP09
• Device Catalogue Number: BREVDISP09
• Device Lot Number: 24J02R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2024
• 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