MAUDE Adverse Event Report: HOLOGIC, INC EVIVA; INSTRUMENT, BIOPSY

Model Number	EVIVA_0913-12
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	04/07/2025
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 on (b)(6) 2025, during an eviva procedure, the physician experienced issues with the suction and vacuum.The needle stopped working after collecting the samples and the vacuum error was displayed.At this point the needle was exchanged to completed the procedure but another incision had to be performed.Patient was under compression for a long time and presented with a breast hematoma.Unknown medical intervention was required to treat the hematoma and the procedure was completed successfully.No other information available.
Additional Manufacturer Narrative
An investigation was completed: it was reported that on (b)(6) 2025, during an eviva procedure, the physician experienced issues with the suction and vacuum.The needle stopped working after collecting the samples and the vacuum error was displayed.At this point the needle was exchanged to complete the procedure, but another incision had to be performed.Patient was under compression for a long time and presented with a breast hematoma.Unknown medical intervention was required to treat the hematoma, and the procedure was completed successfully.The devices were not returned for investigation; therefore, visual and functional inspection were not conducted.The equipment/devices were not returned; visual and function analysis/testing could not be conducted for the described event.However, a complaint trend review has been completed, and it revealed no significant spikes and /or adverse trends recently.No corrective actions (capas or scars) are open for this failure mode.Root cause analysis did not identify a definitive root cause; only contributing factors were found to be associated with the reported event.The investigations included a comprehensive review of device history records, complaint data and risk assessments.Despite these efforts, no single failure mode or specific fault could be conclusively linked to the event.The identified contributing factors were insufficient to establish causality.Conclusion: root cause analysis did not identify a definitive root cause; only contributing factors were found to be associated with the reported event.The investigations included a comprehensive review of device history records, complaint data and risk assessments.Despite these efforts, no single failure mode or specific fault could be conclusively linked to the event.The identified contributing factors were insufficient to establish causality.The event does not trigger escalation to nce, scar, or capa.As per the device history record (dhr) review, the functionality of the devices from the lot is verified during line quality inspections.This event was determined to be an isolated case and not indicative of a systematic issue.Future events will be monitored and trended.Device history record (dhr) review: the dhr was reviewed for the corresponding lot; however, no relevant risk factors were found in the manufacturing process.

• Brand Name: EVIVA
• 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: 21936766
• Report Number: 1222780-2025-00223
• Device Sequence Number: 20792994
• Product Code: KNW
• UDI-Device Identifier: 15420045505322
• UDI-Public: (01)15420045505322(17)260114(10)E24A15RF
• Combination Product (Y/N): N
• PMA/510(K) Number: K180233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 09/16/2025

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: 01/14/2026
• Device Model Number: EVIVA_0913-12
• Device Catalogue Number: EVIVA_0913-12
• Device Lot Number: E24A15RF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2024
• 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