MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW; SNARE, FLEXIBLE

Model Number	M00562691
Medical Device Problem Codes	Retraction Problem (1536); 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	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a sensation short throw was used during endoscopic mucosal resection (emr) procedure performed on (b)(6) 2025.It was reported that during the procedure, as the snare entered the endoscope and reached the polyp position, the snare opened.It reached to the polyp via endoscope; the polyp was captured but could not be cut off.The procedure was completed with another sensation short throw.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1 initial reporter address 1: (b)(6).Block h6: imdrf device code a050702 captures the reportable event of snare loop unable to cut.
Additional Manufacturer Narrative
Block d4 (model number) has been corrected.Block e1: (initial reporter facility name).The reported health care facility is (b)(6).Block h6: imdrf device code a050702 captures the reportable event of snare loop unable to cut.Block h11: investigation results.The returned sensation snare was analyzed, and a visual evaluation noted that the working length (distal section) was bent.A functional evaluation was performed using the 10-inch loop fixture, during which the device was extended and retracted.The loop extended and retracted properly without any issues.Continuity and electrical testing were also performed, and the device was found to be within specifications.No other problems with the device were noted.The reported event of snare loop unable to cut was not confirmed.Product analysis demonstrated that both continuity and electrical tests were within specifications.In addition, the device cannot be fully functionally tested in a way that replicates the anatomical or procedural conditions encountered during actual use.It was also noted that the working length was bent.This damage likely occurred due to the manner in which the device was handled or manipulated during the procedure.Excessive or improper manipulation may have caused the observed defect and contributed to the reported issue.Therefore, the most probable root cause of this complaint is device problem excluded.
Event or Problem Description
It was reported to boston scientific corporation that a sensation short throw was used during endoscopic mucosal resection (emr) procedure performed on (b)(6) 2025.It was reported that during the procedure, as the snare entered the endoscope and reached the polyp position, the snare opened.It reached to the polyp via endoscope, the polyp was captured but could not be cut off.The procedure was completed with another sensation short throw.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 ; 9145716918
• MDR Report Key: 23594888
• Report Number: 3005099803-2025-06135
• Device Sequence Number: 15847476
• Product Code: FDI
• UDI-Device Identifier: 08714729158158
• UDI-Public: (01)08714729158158(17)280110(10)35604597
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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: M00562691
• Device Catalogue Number: 6269
• Device Lot Number: 0035604597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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