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

Model Number	M00560311
Medical Device Problem Codes	Failure to Cut (2587); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of loop failure to cut.
Event or Problem Description
It was reported that a sensation snare was used in the intestinal tract for an endoscopic polypectomy performed on (b)(6) 2026.During the procedure the snare loop presented issues positioning around the polyp and could not cut it.Procedure was completed with an alternative snare.There were no patient complications reported as a result of this event.

• 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: 25359374
• Report Number: 3005099803-2026-02253
• Device Sequence Number: 10679535
• Product Code: FDI
• UDI-Device Identifier: 08714729283904
• UDI-Public: (01)08714729283904(17)260606(10)31773344
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2026

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 Expiration Date: 06/06/2026
• Device Model Number: M00560311
• Device Catalogue Number: M00560311
• Device Lot Number: 0031773344
• Was Device Available for Evaluation?: No
• 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: 05/09/2026
• Supplement Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 08/07/2026
• Date Device Manufactured: 06/07/2023
• 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