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

Model Number	CELEROMARK
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.H6: medical device problem appropriate term/code not available: suggested code: marker not deployed.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 celeromark procedure on (b)(6) 2025, the physician reported that on the post ultrasound guided breast biopsy the marker could be observed deployed.The patient was sent for mammogram in situ.While reviewing the image only the previous clips were visible and the marker could not be observed.Patient was later recalled for another implantation and another marker.Physician reported that the first procedure was a small pocket of gas (¨pseudo clip¨) which could not be differentiated.Another marker was implanted on a separate incision and confirmed implantation.No other information available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that during a celeromark procedure on (b)(6) 2025, the physician reported that on the post ultrasound guided breast biopsy the marker could be observed deployed.The patient was sent for mammogram in situ.While reviewing the image only the previous clips were visible, and the marker could not be observed.Patient was later recalled for another implantation and another marker.Physician reported that the first procedure was a small pocket of gas (¨pseudo clip¨) which could not be differentiated.Another marker was implanted on a separate incision and confirmed implantation.No other information available.The device was not available for return; visual and functional analysis/testing could not be conducted for the described event.The sample was not returned for this complaint.Investigation for this issue was conducted through customer provided information, historical data review, similar complaints analysis, and product design evaluation.Without the returned sample, it is not possible to confirm a definitive root cause of the issue.Conclusion: the reported issue could not be confirmed because the device was not returned.Capa/hra/ncr/scar are not deemed required at this moment by this event.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: the dhr was reviewed for the corresponding lot, and the device was released meeting all qa specifications.

• Brand Name: CELEROMARK
• 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: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 21931524
• Report Number: 1222780-2025-00216
• Device Sequence Number: 15615970
• Product Code: NEU
• UDI-Device Identifier: 15420045503373
• UDI-Public: (01)15420045503373(17)260319(10)E24C19RF
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K023450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2025

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 Expiration Date: 03/19/2026
• Device Model Number: CELEROMARK
• Device Catalogue Number: CELEROMARK
• Device Lot Number: E24C19RF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: Not provided; 11/13/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 04/30/2025; 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2024
• 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