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

Model Number BREVDISP09

Device Problem Failure to Obtain Sample (2533)

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

Event Date 01/12/2024

Event Type  Injury  

Manufacturer Narrative

Needle was returned for investigational purposes : visual inspection was conducted the plastic components were reviewed and there was no damage (top and bottom enclosure, manifold thumbwheel, bearing), however, the tubing was cut then the complaint cannot be confirmed.Hence the complaint cannot be confirmed.This observation will be monitored and trended.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.

Event Description

It was reported that during a brevera procedure on (b)(6) 2024, after targeting and attaching the needle to the system, and placing the needle inside the patient, there was no suction nor vacuum nor saline flow.The needle was removed from the patent and tested and failed, a new needle was placed into the system and the biopsy was completed with the second needle.Service reported a possible defective needle.The patient had to be stuck twice and a second incision was needed.Procedure was completed successfully, and no additional intervention was required.No other information is available.

• 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 park zone b24; san jose 20102 ; CR 20102
• MDR Report Key: 18727137
• MDR Text Key: 335693612
• Report Number: 1222780-2024-00063
• Device Sequence Number: 1
• Product Code: KNW
• 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: 02/16/2024

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: BREVDISP09
• Device Catalogue Number: BREVDISP09
• Device Lot Number: 23H25RX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Initial Date Manufacturer Received: 02/17/2024
• Initial Date FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other