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	06/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: device code a0501 is being used to capture the reportable event of needle detachment.Imdrf code f2301 is being used to capture the reportable event of additional device required.Block h11: device evaluation the device was disposed by customer; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of "needle detachment of device or device component" was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported to boston scientific that an acquire s eus fnb was used to search for tumor in the pancreas during an endoscopic ultrasound and biopsy procedure performed on (b)(6) 2026.During the procedure, for the final puncture, the sheath came off the handle along with the needle at the moment it was inserted in the echoendoscope inside the patient.A kelly forceps was required to remove it and an inspection with the echo endoscopic camera inside the patient confirmed that no piece or fragment remained.The procedure was completed without another device, as the doctor decided that the previous punctures were enough.The patient fully recovered following the procedure, and there were no patient complications reported 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 ; +1(914)571-6918
• MDR Report Key: 50073900
• Report Number: 3005099803-2026-03087
• Device Sequence Number: 10206282
• Product Code: ODG
• UDI-Device Identifier: 00191506030742
• UDI-Public: (01)00191506030742(17)281006(10)37847858
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K223616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00555640
• Device Catalogue Number: M00555640
• Device Lot Number: 0037847858
• 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: 06/30/2026
• Initial Report FDA Received Date: 07/29/2026
• Date Device Manufactured: 10/07/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown