MAUDE Adverse Event Report: HOLOGIC, INC. ATEC SAPPHIRE 100; VACUUM ASSISTED CORE BIOPSY DEVICE

Model Number	ATEC SAPPHIRE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.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.Appropriate term: air injection (soft tissue).
Event or Problem Description
This is the first of two reports related to one event.The second report is filed under 1222780-2020-00143.It was reported that during the biopsy, air was pushed into the breast and it traveled up toward the patient neck.The procedure was aborted.An x-ray was performed but came back unremarkable.The biopsy was not completed.No additional details available.
Additional Manufacturer Narrative
The reported console was received by hologic for investigation.A visual inspection, testing, and dhr review was completed with no problems found, the console passed all testing.We are unable to establish a relationship between the device and the issue reported.

• Brand Name: ATEC SAPPHIRE 100
• Common Device Name: VACUUM ASSISTED CORE BIOPSY DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 10744423
• Report Number: 1222780-2020-00142
• Device Sequence Number: 11706551
• Product Code: KNW
• UDI-Device Identifier: 15420045504028
• UDI-Public: (01)15420045504028(11)90621
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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 Model Number: ATEC SAPPHIRE
• Device Catalogue Number: ATEC SAPPHIRE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 05/27/2021
• 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