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

Model Number	M00555540
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an acquire was used in the duodenum during an endoscopic ultrasound-guided fine needle biopsy (eus fnb) procedure performed on (b)(6) 2025.During procedure, the needle of the acquire was bent.Another acquire was used to complete the procedure.There were no patient complications as a result of this event.This event has been deemed a reportable event based on the investigation finding of sheath punctured.
Additional Manufacturer Narrative
D2b: additional pro code (product code) - odg.H6: imdrf device code a041001 captures the reportable investigation finding of sheath punctured.H11: the returned acquire was analyzed, and it was discovered that the working length was kinked near the luer.Under microscope inspection, the sheath was observed punctured and the tip of the needle was bent.With all the available information, boston scientific concludes the reported event was confirmed.Working length kinked near the luer could be due to the handle was not grabbed or secured carefully, or maybe the weight of the device itself can bend the working length.Since the needle was observed to be kinked, during actuation of the device it did not emerge as intended and instead punctured the sheath.Procedural factors as handling of the device and the technique used by the physician (force applied), most likely contributed to the bending of the needle.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 events.

• 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: 23995893
• Report Number: 3005099803-2026-00106
• Device Sequence Number: 13392751
• Product Code: FCG
• UDI-Device Identifier: 08714729931782
• UDI-Public: (01)08714729931782(17)280218(10)36195209
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 01/07/2026

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: 0036195209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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