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

Model Number	ILS 0914-12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.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 the brown top of the introducer sheath is not properly connected/secure and will fall off while attempting to gain access to the breast to perform the biopsy.A radiologist was stuck with a needle when the brown top detached from the rest of the sheath.Attempts to obtain additional information were unsuccessful.

• Brand Name: ATEC
• Common Device Name: VACUUM ASSISTED CORE BIOPSY DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 11660921
• Report Number: 1222780-2021-00084
• Device Sequence Number: 2899755
• Product Code: KNW
• UDI-Device Identifier: 15420045503199
• UDI-Public: 15420045503199
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

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: 11/13/2022
• Device Model Number: ILS 0914-12
• Device Catalogue Number: ILS 0914-12
• Device Lot Number: 20L13RC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1