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 Type  Injury  

Event Description

It was reported that on (b)(6) 2023, during a brevera procedure the technician was not able to obtain more than 2 samples during the procedure.The equipment was tested by a field engineer, and it found all the samples stuck inside the tubing.The console and equipment were tested, and all operated within manufacturer´s specifications.A field engineer examined the equipment it was found that underutilization of both lavage and aspiration during the exam was the probable cause for the event.The used needle on the event was tested as well as a new one and both needle worked without any issues.This system is operating according to the manufacturer¿s specifications.

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.The equipment was tested by a field engineer, and it found all the samples stuck inside the tubing.The console and equipment were tested, and all operated within manufacturer´s specifications.A field engineer examined the equipment it was found that underutilization of both lavage and aspiration during the exam was the probable cause for the event.The used needle on the event was tested as well as a new one and both needle worked without any issues.This system is operating according to the manufacturer¿s specifications.

• 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: 17243292
• MDR Text Key: 318269514
• Report Number: 1222780-2023-00228
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 15420045507514
• UDI-Public: (01)15420045507514(11)170923
• 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: 06/30/2023

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: BVA00125
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other