MAUDE Adverse Event Report: Hologic, Inc. EVIVA 0913-12T; INSTRUMENT, BIOPSY

Model Number	EVIVA 0913-12T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a breast biopsy there was a "broken plastic introducer sheath." the customer reported the procedure was completed successfully with the same device.They confirmed there was no harm, and no medical or surgical intervention required.Customer outreach confirmed "physician was not able to deployed the first marker as the sheath was broken, however they changed the marker to direct insertion with needle holder and managed to insert via the same incision site that was created initially for the vab by the eviva needle.Thus marker placement did not require additional surgical intervention".No further information is available at this time.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.

• Brand Name: EVIVA 0913-12T
• 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: sarah lawlor ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 50045697
• Report Number: 1222780-2026-00461
• Device Sequence Number: 9589421
• Product Code: KNW
• UDI-Device Identifier: 15420045505339
• UDI-Public: (01)15420045505339(17)270724(10)E25G24RH
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: EVIVA 0913-12T
• Device Catalogue Number: EVIVA 0913-12T
• Device Lot Number: E25G24RH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2025
• 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
• Patient Sex: Unknown