MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION Short Throw; Snare, Flexible

Model Number	M00560301
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a sensation short throw snare was used to remove a gastric polyp in the stomach during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2026.During the procedure, the snare was placed around the polyp and energization was performed; however, the polyp could not be cut, with only slight charring observed.When an attempt was made to remove the snare, it became caught in the tissue, making removal difficult.The patient's position was changed, and it was then possible to remove the device.The procedure was completed with the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of loop failure to cut.

• Brand Name: SENSATION Short Throw
• Common Device Name: Snare, Flexible
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25815552
• Report Number: 3005099803-2026-02810
• Device Sequence Number: 13445166
• Product Code: FDI
• UDI-Device Identifier: 08714729283898
• UDI-Public: (01)08714729283898(17)261023(10)32708556
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131700
• 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,Followup
• Report Date (Section B): 08/17/2026

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: M00560301
• Device Catalogue Number: M00560301
• Device Lot Number: 0032708556
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Supplement Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 07/14/2026
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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