MAUDE Adverse Event Report: HOLOGIC, INC SERTERA BIOPSY DEVICE; INSTRUMENT, BIOPSY

Model Number	SERTERA-14
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
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.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 sertera procedure on (b)(6) 2025, when the radiologist took the sample the device was stuck and wouldn´t let them unsheathe to get the core.The customer responded that the tissue was lost and couldn´t be used.No other information available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that during a sertera procedure on (b)(6) 2025, when the radiologist took the sample, the device was stuck and wouldn´t let them unsheathe to get the core.The customer responded that the tissue was lost and couldn´t be used.The procedure was completed with another device.The device was not returned for this complaint and there was limited patient-related information provided for this event; therefore, a thorough investigation was not carried out.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.According to previous year´s data of similar complaints, of 58 ¿function | would not arm / retract / cock / fire¿ cases, only 1 were found with issue found in this complaint.Capa/hra/ncr/scar are not deemed required at this moment by this event since it is considered as isolated event.Future events will be monitored and trended.Device history record (dhr) review: the dhr was reviewed for the corresponding lot, and no relevant risk factors were found in the manufacturing process.

• Brand Name: SERTERA BIOPSY DEVICE
• 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: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 21261425
• Report Number: 1222780-2025-00043
• Device Sequence Number: 9538970
• Product Code: KNW
• UDI-Device Identifier: 15420045504066
• UDI-Public: (01)15420045504066(17)260902(10)E24J02RV
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K150169
• 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): 11/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2026
• Device Model Number: SERTERA-14
• Device Catalogue Number: SERTERA-14
• Device Lot Number: E24J02RV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2024
• 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