MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACQUIRE? S; ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY

Model Number	M00555640
Medical Device Problem Codes	Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h3: the device was returned for analysis; however, the investigation is still in progress.A supplemental report will be submitted when the investigation is complete or if additional relevant information becomes available.Block h6: device code a180104 is being used to capture the reportable event of device foreign material present in device.
Event or Problem Description
It was reported to boston scientific that an acquire? s was intended to be used on a procedure performed on (b)(6) 2026.During the procedure, it was reported that the stylet could not pass because it interfered with what appeared to be a foreign object.The event occurred outside the patient.The procedure was completed with another device of the same model.There were no adverse events reported for the patient during or following the procedure as a result of this event.

• Brand Name: ACQUIRE? S
• Common Device Name: ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
• 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: 25256618
• Report Number: 3005099803-2026-02033
• Device Sequence Number: 5496151
• Product Code: ODG
• UDI-Device Identifier: 00191506030742
• UDI-Public: (01)00191506030742(17)281029(10)38021198
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K223616
• 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): 07/10/2026

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: M00555640
• Device Catalogue Number: M00555640
• Device Lot Number: 0038021198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2025
• 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