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	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block e1 (initial reporter address 1): (b)(6).Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.
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 supporting force was insufficient; during snaring attempts, the target polyp consistently slipped and could not be cut.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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 supporting force was insufficient; during snaring attempts, the target polyp consistently slipped and could not be cut.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block e1 (initial reporter address 1): (b)(6).Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems block h11: investigation results: the device was not returned for analysis; therefore, product analysis could not be carried out.For this reason and due to the lack of evidence, it is unable to confirm the reported event.It was confirmed this device met manufacturing specifications prior to distribution, and there were no manufacturing deviations which could have contributed to the reported event.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.The product was not returned for analysis to identify any defect with the device.Additionally, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: 25216862
• Report Number: 3005099803-2026-01961
• Device Sequence Number: 21325403
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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: 04/24/2026
• Supplement Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 08/28/2026
• 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