MAUDE Adverse Event Report: HOLOGIC, INC. ATEC; 9G INTRODUCER LOCALIZATION SET FOR ATEC 0914-20MR HANDPIECE

Model Number	ILS 0914-20
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2018
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.Reference internal complaint: (b)(4).
Event or Problem Description
It was reported a physician performed a breast biopsy procedure on (b)(6) 2018 and the patient was discharged home.On (b)(6) 2018, the patient returned for her marker placement.On (b)(6) 2018, during the excision procedure the technician noticed a plastic piece.The piece was removed.There was no patient injury reported.

• Brand Name: ATEC
• Common Device Name: 9G INTRODUCER LOCALIZATION SET FOR ATEC 0914-20MR HANDPIECE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 7673548
• Report Number: 1222780-2018-00152
• Device Sequence Number: 10974737
• Product Code: KNW
• UDI-Device Identifier: 15420045503205
• UDI-Public: (01)15420045503205(10)17K12RA
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/25/2018

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: 10/12/2019
• Device Model Number: ILS 0914-20
• Device Catalogue Number: ILS 0914-20
• Device Lot Number: 17K12RA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATEC SECURMARK: LOT UNK