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

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	04/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on april 29, a brevera procedure was performed, and while doing a breast biopsy the radiologist went to fire the needle and the device would not fire.The staff changed the needle and rebooted the system and it still would not fire.It ended up being the brevera device and not the needles.The patient was brought in later in the week once the device was replaced.No additional information available.
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.We are currently unable to establish a relationship between the device and the issue reported.H3: a field engineer examined the device and found multiple errors with ¿fails to fire¿ during the procedure.The field engineer replaced the driver and verified the operation the system is functioning properly and meets all manufacturer specifications.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 additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.

• Brand Name: BREVERA BREAST BIOPSY SYSTEM
• Common Device Name: BIOPSY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose, MA 20102 ; CR 20102
• MDR Report Key: 19371286
• Report Number: 1222780-2024-00179
• Device Sequence Number: 7689197
• Product Code: KNW
• UDI-Device Identifier: 15420045507517
• UDI-Public: (01)15420045507517(11)210810
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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?: Yes
• 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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female