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

Model Number	M00562650
Medical Device Problem Codes	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	09/30/2024
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 to boston scientific corporation that a sensation short throw was used for a polyp in the colon for a polypectomy procedure performed on (b)(6) 2024.During the procedure, on its first cut it loses quality and does not cut.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 h2: additional information: block e1 (initial reporter facility name, initial reporter address 1, initial reporter city and initial reporter zip/post code).Block h6: imdrf device code a050702 captures the reportable event of loop failure to cut.
Event or Problem Description
It was reported to boston scientific corporation that a sensation short throw was used for a polyp in the colon for a polypectomy procedure performed on (b)(6) 2024.During the procedure, on its first cut it loses quality and does not cut.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 h6: imdrf device code a050702 captures the reportable event of loop failure to cut.Block h11: investigation results: a sensation snare was received for analysis, and it was found during visual inspection that the working length was bent and kinked at multiple sections.A continuity and electrical test were performed, and the device was noted to be within specification.No other problems with the device were noted.The reported complaint of loop failure to cut was unable to be confirmed.This problem likely occurred due to the manner in which the device was handled, and manipulation may have caused the reported and encountered failure.Excessive manipulation of the device without enough care could have induced the defect found.Additionally, the device cannot be functionally tested by emulating the anatomical or procedural factors encountered during the procedure.Based on the information available and the returned device analysis, a conclusion of no problem detected was assigned to this investigation since the reported allegation was not observed.
Event or Problem Description
It was reported to boston scientific corporation that a sensation short throw was used for a polyp in the colon for a polypectomy procedure performed on (b)(6) 2024.During the procedure, on its first cut it loses quality and does not cut.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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 20504939
• Report Number: 3005099803-2024-05330
• Device Sequence Number: 12838033
• Product Code: FDI
• UDI-Device Identifier: 08714729748069
• UDI-Public: (01)08714729748069(17)260821(10)32272651
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2025

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: 08/21/2026
• Device Model Number: M00562650
• Device Catalogue Number: M00562650
• Device Lot Number: 0032272651
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 10/17/2024; 04/21/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/07/2024; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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