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

Model Number	M00555640
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of the two acquire needles used for single patient during one procedure.It was reported to boston scientific corporation that an acquire needle was to be used in the lever during a biopsy procedure performed on (b)(6) 2025.During procedure, the needle was detached, and the sheath knob was broken.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of needle detachment of device or device component.

• 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: 23854187
• Report Number: 3005099803-2025-06804
• Device Sequence Number: 20104027
• Product Code: ODG
• UDI-Device Identifier: 00191506030742
• UDI-Public: (01)00191506030742(17)270620(10)34278710
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 05/22/2026

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: 0034278710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 06/20/2024
• 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: 60 KG