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

Model Number	M00562650
Medical Device Problem Codes	Break (1069); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to the fourth of four sensation snares used during the same procedure.It was reported to boston scientific corporation that a sensation snares was used in the colon during a colonoscopy procedure performed on (b)(6) 2026.It was reported that the snare was unable to cut due to handle breakage.A fourth sensation snares was used; however, the same problem happened.The procedure was completed with another sensation snares.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 cutting problems.
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.Block h11: the device was not returned for analysis; therefore, a technical analysis could not be performed.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 loop failure to cut and handle break were due to the physician's technique during the procedure or were associated with a device malfunction.Without proper evaluation of the device, the most probable causes contributing to the event cannot be determined.Additionally, the product record review did not reveal any potential product quality issues or evidence of new patient harm.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
Note: this report pertains to the fourth of four sensation snares used during the same procedure.It was reported to boston scientific corporation that a sensation snares was used in the colon during a colonoscopy procedure performed on (b)(6) 2026.It was reported that the snare was unable to cut due to handle breakage.A fourth sensation snares was used; however, the same problem happened.The procedure was completed with another sensation snares.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: 25070835
• Report Number: 3005099803-2026-01622
• Device Sequence Number: 10748231
• Product Code: FDI
• UDI-Device Identifier: 08714729748069
• UDI-Public: (01)08714729748069(17)281208(10)38143328
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/21/2026

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: M00562650
• Device Catalogue Number: M00562650
• Device Lot Number: 0038143328
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 05/21/2026
• Date Device Manufactured: 12/09/2025
• 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