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

Model Number BREV100

Device Problem Failure to Obtain Sample (2533)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2024

Event Type  Injury  

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.

Event Description

It was reported that on january 4th, a brevera procedure was performed and an error occurred during the procedure after the needle was inserted into the breast.The needle made an odd sound when firing, and then got a system error.The doctor removed the needle from the patient and connected a new needle, and the same issue when firing.The staff rebooted the system and attempted to test the fire needle, getting the same error and sound.Confirmed no injury to the patient, and the procedure had to be rescheduled.A field engineer examined the equipment and tested the equipment, multiple mock biopsies, firing test needles into dense packing foam and completing core biopsies.Could not duplicated failure or errors.Suspected possible issue with defective needles or disposables.System passed al manufacturing specifications.Patient completed a rescheduled biopsy on january 5th without incident.

• Brand Name: BREVERA BREAST BIOPSY SYSTEM
• Type of Device: 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: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 18634253
• MDR Text Key: 334494451
• Report Number: 1222780-2024-00036
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 15420045507760
• UDI-Public: (01)15420045507760(11)220929
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/02/2024

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
• Device Operator: Health Professional
• Device Model Number: BREV100
• Device Catalogue Number: BREV100
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other