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

Model Number ATEC 0909-20

Device Problem Failure to Obtain Sample (2533)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  Injury  

Event Description

It was reported that during a procedure on (b)(6) 2023, the atec needle was reported stuck during the procedure.The procedure was reported as aborted and no additional harm was reported to the patient.No other information is available.

Manufacturer Narrative

A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.H3: the device was received for evaluation, and a visual inspection was conducted and there were no signs of physical damage in the device.However, the introducer is missing.Functional testing was conducted, and the device passed the setup and test phases successfully, during the visual inspection there were no signs of cutting edges that could have caused the needle to get stuck, the tissue acquisition test was performed and no issues were detected during the test and at the end of the test, the needle out of the sample tissue without issues, the failure reported was not reproduced.Hence, the complaint cannot be confirmed.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.

• Brand Name: ATEC NEEDLE
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough 01752
• Manufacturer (Section G): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 18806588
• MDR Text Key: 336546976
• Report Number: 1222780-2024-00081
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/29/2024

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
• Device Operator: Health Professional
• Device Model Number: ATEC 0909-20
• Device Catalogue Number: ATEC 0909-20
• Device Lot Number: E23F29RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female