MAUDE Adverse Event Report: Hologic, Inc. ATEC Introducer; INSTRUMENT, BIOPSY

Model Number	ILS 0914-20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported the mri introducer valve, also known as silicone elastomer or silicone valve, pushed into the introducer as the needle advanced into the introducer.The silicone elastomer remained in the patient¿s breast which was confirmed by a post-procedural mammogram.This resulted in the patient requiring surgery to remove the silicone elastomer.No further information is available at this time.
Additional Manufacturer Narrative
Device history record (dhr) review was unable to be conducted for the device as the reported lot number (e26812ra) did not populate in the hologic system, and no serial information was reported.A follow-up report will be submitted in the event additional information is received.

• Brand Name: ATEC Introducer
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): Hologic, Inc.; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): Hologic, Inc.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sarah lawlor ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 50010953
• Report Number: 1222780-2026-00453
• Device Sequence Number: 14913259
• Product Code: KNW
• UDI-Device Identifier: 05420045503208
• UDI-Public: 05420045503208
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ILS 0914-20
• Device Catalogue Number: ILS 0914-20
• Device Lot Number: E26812RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown