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

Model Number	BREV09
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.
Event or Problem Description
It was reported that during a breast biopsy procedure on (b)(6) 2020 the brevera sheath began to twist and crumple when the physician attempted to remove the needle from the biopsy site.There was no impact or harm reported to the patient.No additional details at this time.

• Brand Name: BREVERA BIOPSY SYSTEM WITH CORLUMINA IMAGING TECHNOLOGY
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, ma
• MDR Report Key: 10002772
• Report Number: 1222780-2020-00076
• Device Sequence Number: 19355186
• Product Code: KNW
• UDI-Device Identifier: 15420045507777
• UDI-Public: (01)15420045507777(17)200611(10)6622432
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2020
• Device Model Number: BREV09
• Device Catalogue Number: BREV09
• Device Lot Number: 6622432
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1