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

Model Number	M00555580
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	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of needle detached.
Event or Problem Description
It was reported to boston scientific corporation that an acquire eus fnb needle was used in the liver during an eus guided liver biopsy procedure performed on (b)(6) 2024.During the procedure, it was observed that the needle was not moving in conjunction with the handle.Upon retracting the needle, it was found that the needle has detached from the handle.The same problem was observed when the device was inspected outside of the patient.A video was provided which shows the device was inspected outside of the patient and the needle was found detached inside the working length.No part of the device detached inside the patient.Another new needle was used to complete the procedure.There were no patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an acquire eus fnb needle was used in the liver during an eus guided liver biopsy procedure performed on (b)(6) 2024.During the procedure, it was observed that the needle was not moving in conjunction with the handle.Upon retracting the needle, it was found that the needle has detached from the handle.The same problem was observed when the device was inspected outside of the patient.A video was provided which shows the device was inspected outside of the patient and the needle was found detached inside the working length.No part of the device detached inside the patient.Another new needle was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of needle detached.Block h11: the returned acquire was analyzed, and a visual inspection found the working length was kinked.As a functional test the device was actuated and found the needle was unable to extend.The device was misassembled and was found that the needle wasn't detached but was broken.A video was provided which shows the device was inspected outside of the patient and the needle was found detached inside the working length.The reported event of needle detachment of device or device component could not be confirmed during analysis because the needle wasn't detached but was broken.For this reason, this event will be addressed as no problem detected.The investigation finding of working length kinked is most likely due to procedural factors such as handling of the device or the technique used by the physician (force applied).These factors could have led to the damage observed on the device, and also caused the needle to kink and break, particularly if excessive force was used during needle extension or retraction, as seen when the handle was disassembled and the needle exposed.For this reason, these events are catalogued as "adverse event related to procedure" because the adverse events occurred during the procedure, and the device had no influence on 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: 20360602
• Report Number: 3005099803-2024-04886
• Device Sequence Number: 20854575
• Product Code: ODG
• UDI-Device Identifier: 08714729931829
• UDI-Public: 08714729931829
• 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): 10/14/2025

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: M00555580
• Device Catalogue Number: M00555580
• Device Lot Number: 0033375289
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 48 KG