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

Model Number	ATEC PEARL
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	11/13/2024
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.
Event or Problem Description
It was reported that during an atec procedure on (b)(6) 2024, the system had reduced saline flow.The needle was tested correctly.The lack of lavage caused a hematoma in the patient´s breast.The procedure was completed successfully and no additional incision were made.The console was returned and investigated it was observed that the pressure switches and air motor pressure were out of calibration.A preventive maintenance was performed, calibrated and tested.No other information available.

• Brand Name: ATEC PEARL
• 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 ; CR 20102
• MDR Report Key: 20913964
• Report Number: 1222780-2024-00470
• Device Sequence Number: 20945840
• Product Code: KNW
• UDI-Device Identifier: 15420045506855
• UDI-Public: (01)15420045506855
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 12/12/2024

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 PEARL
• Device Catalogue Number: ATEC PEARL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown