MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACQUIRE; BIOPSY NEEDLE

Model Number	M00555540
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's date of birth and exact age is unknown; however it was reported that the patient was over the age of 18.Block d2b: additional pro code (product code) - odg block h6: device code a0501 captures the reportable event of needle detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that an acquire eus fna needle was used in the esophagus during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2025.During the procedure, the needle was broken from the sheathe hub in the middle of the needle.The middle part of the needle completely got broken and detached outside of the patient.The procedure was completed using an alternate device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block a2: patient's date of birth and exact age is unknown; however it was reported that the patient was over the age of 18.Block d2b: additional pro code (product code) - odg.Block h6: device code a0501 captures the reportable event of needle detachment of device or device component.Block h11: the returned acquire biopsy needle was analyzed, and a product analysis found the handle broken.The working length was observed kinked and bent.The needle was found not broken but kinked.With all the available information, boston scientific concludes that the reported needle detachment of device or device component was not confirmed.The handle was returned broken; this was caused by excessive force when inserting the device into the scope or by excessive manipulation of the device during the procedure.This damage also caused the needle inside the handle to kink.Also, the working length was observed bent and kinked.Procedural or anatomical conditions could have affected the device's performance and integrity.It is likely these events were caused by operational factors such as handling, technique, or device manipulation.Therefore, the most probable root cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on event.Since the reported needle detachment of device or device component couldn't be confirmed during analysis this event will be addressed as no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that an acquire eus fna needle was used in the esophagus during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2025.During the procedure, the needle was broken from the sheathe hub in the middle of the needle.The middle part of the needle completely got broken and detached outside of the patient.The procedure was completed using an alternate device.There were no patient complications as a result of this event.

• Brand Name: ACQUIRE
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 21280067
• Report Number: 3005099803-2025-00273
• Device Sequence Number: 9320400
• Product Code: FCG
• UDI-Device Identifier: 08714729931782
• UDI-Public: 08714729931782
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K160845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00555540
• Device Catalogue Number: M00555540
• Device Lot Number: 0034549666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/01/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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
• Patient Sex: Male