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
Event or Problem Description
It was reported to boston scientific corporation that a sensation snare was used in the intestinal tract during an endoscopic polypectomy procedure performed on (b)(6) 2026.During the procedure, the physician tried to cut a polyp, but the support force was not enough to successfully cut the target polyp, and the loop continuously slide off the surface of the tissue.The procedure was completed with a different 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 (device 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 ; 9145716918
• MDR Report Key: 25368538
• Report Number: 3005099803-2026-02281
• Device Sequence Number: 13092520
• 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
• Serviced by Third Party (Y/N): Unknown
• 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): 07/07/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 07/07/2026
• 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