MAUDE Adverse Event Report: HOLOGIC, INC ATEC 0914-12MR; INSTRUMENT, BIOPSY

Model Number	ATEC 0914-12MR
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
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 is reported that during an atec procedure on (b)(6), 2025, the user observed a clear, greasy substance on the specimen collection basket.It is reported that this substance interfered with the ability of the device to properly seal, resulting in air leakage.As a result, it is reported that the procedure was aborted after the initial incision had been made and the patient had to return on another day for another biopsy, requiring a second incision site.No further information is currently available.
Additional Manufacturer Narrative
An investigation was conducted: it is reported that during an atec procedure on (b)(6), 2025, the user observed a clear, greasy substance on the specimen collection basket.It is reported that this substance interfered with the ability of the device to properly seal, resulting in air leakage.As a result, it is reported that the procedure was aborted after the initial incision had been made and the patient had to return on another day for another biopsy, requiring a second incision site.The device was returned to the post market quality laboratory for investigation.Visual inspection was conducted and revealed visible grease in the filter canister; functional testing was not conducted.The visual inspection identified the excessive amount of grease in the filter canister, consistent with the initial evaluation, confirming the failure.The investigation determined that the most probable cause of the device issue was an excessive amount of grease, as identified during the visual inspection.The excessive grease in the filter canister is present during manufacturing, and is typically found in the filter tissue area, this situation is currently not considered a critical step to be performed by an automated process, and the observed grease is biocompatible and most probably do not present any kind of risk or harm to the patient because of its composition; passed biocompatibility testing as established and required per iso-10993-1:2009 for an external communicating device, with limited (= 24 hours) contact duration.However, the concern is no longer only about biocompatibility.The customer reported that this substance interfered with the device¿s ability to seal properly, causing air leakage.It is important to note that the following tests were part of the initial validation process: tensile strength for filter canister to quad set tubing joint.Verification report for quad set component: suction connector.Both tests passed successfully.The grease is applied manually and although this step is not currently considered critical, an engineering change order (eco) introduced a new container for grease application on the tissue filter component to help prevent similar issues in the future.Conclusion: the reported issues have been confirmed, and the most probable root cause has been identified.A comprehensive review was conducted, including device history records, complaint data, and risk assessments.The root cause was previously addressed through an eco.The eco covered the failure mode reported and implemented corrective actions.Capa/hra/ncr/scar are not deemed required at this moment by this 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: ATEC 0914-12MR
• 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: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 22441254
• Report Number: 1222780-2025-00367
• Device Sequence Number: 7473821
• Product Code: KNW
• UDI-Device Identifier: 15420045504875
• UDI-Public: (01)15420045504875(17)270214(10)E25B14RA
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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 Model Number: ATEC 0914-12MR
• Device Catalogue Number: ATEC 0914-12MR
• Device Lot Number: E25B14RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown