MAUDE Adverse Event Report: HOLOGIC, INC SECURMARK; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	SMARK-EVIVA-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.
Event or Problem Description
It was reported by the user site that while attempting to complete a procedure with a securmark biopsy site marker on (b)(6), the marker was deployed; however, "we believe the marker was stuck to the end of the introducer." the user further reports that a second marker deployment was attempted with a second device from the same lot and "the marker deployed but there was no marker present when the md pulled the introducer out and tried to confirm the marker deployment.There was a piece of plastic that deployed, but no marker present." additional information was obtained from the user, and it is reported that the "plastic" was observed upon removing the introducer from the patient and "the plastic did not stay in the patient." no patient injury was reported, and the marker deployment was completed with another device.No further information is currently available.

• Brand Name: SECURMARK
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 24562775
• Report Number: 1222780-2026-00110
• Device Sequence Number: 21047994
• Product Code: NEU
• UDI-Device Identifier: 05420045503611
• UDI-Public: (01)05420045503611(17)260724(10)E25G24RA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062528
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2026

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: 07/24/2026
• Device Model Number: SMARK-EVIVA-13
• Device Catalogue Number: SMARK-EVIVA-13
• Device Lot Number: E25G24RA
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/17/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown