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

Model Number	SMARK-M-SS2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
Event or Problem Description
It was reported that during a smark-m-ss2 for atec procedure on (b)(6) 2025, an artifact was observed in the patient's breast after an mri biopsy.It is reported that the procedure was completed successfully; however, the customer reports that the patient required additional medical or surgical intervention.No further information is available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that during an atec procedure on (b)(6) 2025, an artifact was observed in the patient's breast after an mri biopsy, in addition to the smark-m-ss2 marker that was deployed at the time.It is reported that the procedure was completed successfully; however, the customer reports that the patient required additional medical or surgical intervention.Initially, the complaint from the customer was filed against the atec biopsy device and marker.However, following investigation, it was determined that particles resembling those described in the customer complaint were found inside the introducer's sheath.As the customer confirmed that the atec introducer localization system (ils) was used during the procedure, it has been determined that the foreign material originated from the atec ils.Mdr 1222780-2025-00359 was previously submitted against the atec ils for this event.As a result, this event is deemed no longer reportable for this device.

• Brand Name: SECURMARK MRI
• 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: 22031098
• Report Number: 1222780-2025-00254
• Device Sequence Number: 20936286
• Product Code: NEU
• UDI-Device Identifier: 05420045503987
• UDI-Public: 05420045503987
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K102608
• 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): 01/09/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: SMARK-M-SS2
• Device Catalogue Number: SMARK-M-SS2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 01/09/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown