MAUDE Adverse Event Report: HOLOGIC, INC. ATEC; 9G INTRODUCER LOCALIZATION SET FOR ATEC HANDPIECE

Model Number	ILS 0914-20
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/12/2018
Type of Reportable Event	Serious Injury
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.(b)(4).
Event or Problem Description
It was reported a physician performed an atec breast biopsy procedure on (b)(6) 2018 and when the physician was withdrawing the needle from the introducer there was resistance that caused the needle to "deflect up" when removing and caused the physician to receive a needle stick.It is unknown if intervention was required.We have been unable to obtain additional information surrounding this event.

• Brand Name: ATEC
• Common Device Name: 9G INTRODUCER LOCALIZATION SET FOR ATEC HANDPIECE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 7719898
• Report Number: 1222780-2018-00168
• Device Sequence Number: 1065176
• Product Code: KNW
• UDI-Device Identifier: 15420045503205
• UDI-Public: (01)15420045503205(10)18A04RH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

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: 01/04/2020
• Device Model Number: ILS 0914-20
• Device Catalogue Number: ILS 0914-20
• Device Lot Number: 18A04RH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1