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	05/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code (a050702) captures the reportable event of (device failure to cut).
Event or Problem Description
It was reported to boston scientific corporation that a sensation snare was used in the digestive tract during an endoscopic polypectomy procedure performed on (b)(6) 2026.During the procedure, the physician tried to cut a polyp, but the loop continuously slide off the surface of the tissue.As a result, the support force was insufficient, and the snare was unable to successfully cut the target polyp.The procedure was completed with an alternative device.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: 25317998
• Report Number: 3005099803-2026-02173
• Device Sequence Number: 20147280
• 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): 08/24/2026

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: 05/06/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 08/25/2026
• 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