MAUDE Adverse Event Report: HOLOGIC, INC. ATEC; 9G INTRODUCER LOCALIZATION SET FOR ATEC 0914-12MR HANDPIECE

Model Number	ILS 0914-12
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	06/01/2018
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) 2018 and the tip of the plastic introducer remained inside the patient.The physician removed the piece and completed the procedure.There was no patient injury.The patient was discharged home.
Additional Manufacturer Narrative
Corrected data in sections: common device name- numbers 2, 4.And g5, number 5.

• Brand Name: ATEC
• Common Device Name: 9G INTRODUCER LOCALIZATION SET FOR ATEC 0914-12MR HANDPIECE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 7602845
• Report Number: 1222780-2018-00133
• Device Sequence Number: 10993083
• Product Code: KNW
• UDI-Device Identifier: 15420045503199
• UDI-Public: (01)15420045503199(10)17F09R
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2018

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: Physician
• Device Expiration Date: 06/09/2019
• Device Model Number: ILS 0914-12
• Device Catalogue Number: ILS 0914-12
• Device Lot Number: 17F09R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1