MAUDE Adverse Event Report: HOLOGIC, INC. ATEC BREAST BIOPSY AND EXCISION SYSTEM; BREAST BIOPSY INSTRUMENT

Model Number	ASY-09265
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2017
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.(b)(4).
Event or Problem Description
It was reported a physician performed a breast biopsy procedure on (b)(6) 2017 and "during the procedure the colored ring from the introducer sheet at the back side broke off.This created an open connection with the breast tissue." there was no patient harm and the procedure was completed with a second device.
Additional Manufacturer Narrative
The device was received and evaluated on february 15, 2018.The investigator verified that the trim ring on the introducer sheath is broken.It cannot be determined how the breakage occurred.

• Brand Name: ATEC BREAST BIOPSY AND EXCISION SYSTEM
• Common Device Name: BREAST BIOPSY INSTRUMENT
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 7137537
• Report Number: 1222780-2017-00294
• Device Sequence Number: 93921
• Product Code: KNW
• UDI-Device Identifier: 15420045503199
• UDI-Public: (01)15420045503199(10)603578
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P010013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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: Physician
• Device Expiration Date: 03/07/2018
• Device Model Number: ASY-09265
• Device Catalogue Number: ASY-09265
• Device Lot Number: 603578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 06/17/2020
• 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: Required Intervention; Disability