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

Model Number	M00562692
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation results of cautery pin detached.Block h11: investigation results: the returned sensation snare device was analyzed, and a visual evaluation noted that the handle cannula was detached.Also, it was found that the cautery pin was loosened.In order to analyze this component, it was fully detached manually, and it was found that the cautery pin was not damaged.The device was analyzed under magnification, and it was found that the handle cannula had the manufacturing crimping mark and the torque mark.Due to this condition, the functional test cannot be performed.No other problems with the device were noted.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.Investigation found that the handle cannula and cautery pin were detached.These problems likely have occurred due to the manner in which the device was handled and manipulated, which may have caused the reported and encountered problems.Excessive manipulation of the device without enough care could have induced the defects found.Also, these problems could have occurred due to the way the active cord was connected or disconnected from the cautery pin (2 in 1 connector), which may have caused the cautery pin to become detached; as a result, the handle cannula became detached as well.It is important to mention that the handle cannula had the manufacturing crimping and torque marks.Regarding the reported event of a loop retraction problem, since the device cannot be actuated and due to the device condition, it is not possible to confirm if the device was unable to retract.Taking all available information into consideration, the most probable cause of this complaint is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported to boston scientific corporation that a sensation snare device was used in the colon during an unknown procedure performed on (b)(6) 2026.During the procedure, the snare would not completely close after its first opening.The procedure was completed with another sensation snare device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation findings of the cautery pin detached.Please see block h11 for full investigation details.

• 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: 24899181
• Report Number: 3005099803-2026-01386
• Device Sequence Number: 15622535
• Product Code: FDI
• UDI-Device Identifier: 08714729268826
• UDI-Public: (01)08714729268826(17)281127(10)38065081
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: M00562692
• Device Catalogue Number: 6269-20
• Device Lot Number: 0038065081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/16/2026
• Date Device Manufactured: 11/28/2025
• 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