MAUDE Adverse Event Report: HOLOGIC, INC. BREVERA BIOPSY SYSTEM WITH CORLUMINA IMAGING TECHNOLOGY; BIOPSY INSTRUMENT

Model Number	BREV09
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.
Event or Problem Description
It was reported that the equipment and needle were set up and tested correctly.After taking 6 tissue samples there were no calcifications visible.After taking 18 tissue samples, only 8 very small samples were available.It was unknown if the samples would be sufficient for diagnosis.Additional information obtained from the customer confirmed that the patient will need to undergo another biopsy due to insufficient tissue sampling.

• Brand Name: BREVERA BIOPSY SYSTEM WITH CORLUMINA IMAGING TECHNOLOGY
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 11591287
• Report Number: 1222780-2021-00066
• Device Sequence Number: 4108402
• Product Code: KNW
• UDI-Device Identifier: 15420045507777
• UDI-Public: 15420045507777
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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: 10/13/2021
• Device Model Number: BREV09
• Device Catalogue Number: BREV09
• Device Lot Number: 10151249
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other