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

Model Number	M00562670
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Cut (2587); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of snare loop unable to cut.Imdrf device code a150208 captures the reportable event of loop entrapment.
Event or Problem Description
It was reported to boston scientific that a sensation short throw snare was used to remove a large colorectal sessile polyp during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, the device would not coagulate the polyp, and the snare became stuck.It was necessary to cut the snare and attempt retrieval of the polyp and snare manually.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific that a sensation short throw snare was used to remove a large colorectal sessile polyp during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, the device would not coagulate the polyp, and the snare became stuck.It was necessary to cut the snare and attempt retrieval of the polyp and snare manually.The procedure was completed with another of the same 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 snare loop unable to cut.Imdrf device code a150208 captures the reportable event of loop entrapment.Block h11: investigation result the complaint device was not returned; therefore, product analysis could not be performed.For this reason, and due to the lack of evidence, the reported event was unable to be confirmed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on the event description and the information provided by the customer, there is insufficient evidence to determine whether the reported events were related to the physician technique during the procedure or to a potential device malfunction.Additionally, a review of the most relevant complaint information, including the product record review, confirmed that the device met all required manufacturing specifications and passed all inspections and controls.No abnormalities were identified during the assembly process.Because the product was not returned for analysis, it was not possible to assess the device for potential defects.Furthermore, the impact code of additional device required will be classified as an adverse event related to procedure, as the adverse event occurred due to issues encountered during the procedure rather than a confirmed device malfunction.Based on a thorough review of the 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 ; 9145716918
• MDR Report Key: 23548073
• Report Number: 3005099803-2025-05948
• Device Sequence Number: 21262282
• Product Code: FDI
• UDI-Device Identifier: 08714729748083
• UDI-Public: (01)08714729748083(17)261214(10)33068041
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 03/31/2026

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: M00562670
• Device Catalogue Number: M00562670
• Device Lot Number: 0033068041
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 12/15/2023
• 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