MAUDE Adverse Event Report: HOLOGIC, INC ATEC INTRODUCER; INSTRUMENT, BIOPSY

Model Number	ILS 0914-20
Medical Device Problem Codes	Material Fragmentation (1261); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.H6: appropriate term/code not available: component code suggested code: introducer.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 an atec procedure in (b)(6) 2025, while using the atec introducer localization set for mri and mri breast biopsy.The trocar was difficult to place through the introducer and met some initial resistance but subsequently was able to slide through easily on repeat.Check performed prior to placement in patient.Following the uneventful biopsy, post biopsy mammogram showed a small high-density ring adjacent to the biopsy marker which was not in patient´s breast on pre procedure mammogram.No other information available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that during an atec procedure on (b)(6) 2025, while using the atec introducer localization set for mri and mri breast biopsy, the trocar was difficult to place through the introducer and met some initial resistance but subsequently was able to slide through easily on repeat.Check performed prior to placement in patient.Following the uneventful biopsy, post biopsy mammogram showed a small high-density ring adjacent to the biopsy marker which was not in patient´s breast on pre procedure mammogram.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 device was not returned for this complaint, and only limited patient-related information was provided.Based on the available information, the customer reported that the trocar was difficult to place through the introducer and met some initial resistance, which was considered relevant to the failure mode.Investigation of this issue was conducted through customer-provided information, historical complaint review, analysis of similar events, and evaluation of product design.The root cause of the reported issue is associated with inadequate manufacturing process controls at the supplier, which resulted in introducer sheath components being produced with internal burrs and residual debris.A health risk assessment was opened to address this specific issue and will establish the need for updates to risk management.These imperfections were not effectively detected during the previous inspection process, allowing foreign particles to remain on the components and subsequently be present in the final assembled product.A detailed review of historical complaints and nonconformance events confirmed that the debris found during internal inspections matched the particles described in multiple complaints, establishing a direct link between the supplier¿s process deficiencies and the reported failure mode.To address this issue, a scar was issued to the supplier, requiring the implementation of enhanced process controls, burr removal procedures, and improved cleaning steps at the supplier¿s facility.Conclusion: the reported issues have been confirmed, and the most probable root cause has been identified.A health risk assessment will establish the need for updates to risk management.Additionally, an nce was escalated to a scar; through this scar, containment and corrective actions were implemented by the supplier, and the root cause was identified for further investigation and resolution.Capa or a new hra, scar or nce are not deemed required by this event.Future events will be monitored and trended.Complaint confirmed: yes.Device history record (dhr) review: the dhr review was not conducted since the lot/serial number was not provided by the complainant.

• Brand Name: ATEC INTRODUCER
• 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: 21901211
• Report Number: 1222780-2025-00200
• Device Sequence Number: 11777150
• Product Code: KNW
• UDI-Device Identifier: 05420045503208
• UDI-Public: 05420045503208
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/04/2026

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: ILS 0914-20
• Device Catalogue Number: ILS 0914-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 02/04/2026
• 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