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

Model Number	M00562691
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf component code g0405209 captures the reportable investigation result of cautery pin detached.Block h11: investigation result the returned sensation snare was analyzed and a visual evaluation noted that that the cautery pin was loosened and was not damaged.Also, the handle cannula was detached.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.Additionally, it was found that the working length and wire were kinked.No other device problems were noted.The product analysis identified that the cautery pin was loosened.It was also found that the handle cannula was detached.The device was analyzed under magnification, and it was found that the handle cannula had the manufacturing crimping mark and the torque mark.Additionally, it was found that the working length and wire were kinked.These issues reported failures likely have occurred due to the manner as in which the device was handled and manipulated may have caused the reported and encountered failures.Excessive manipulation of the device without enough care could have induced the defects found.Based on all gathered information, the most probable root cause selected assigned is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a sensation snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2025.It was reported that during the procedure, the first snare was difficult to open/close, then handle popped and noted a silver piece in handle broke and was unable to close handle.The procedure was completed with another sensation snare device.There were no patient complications as a result of this event.Based on the investigation result of the cautery pin was loosened; this is now a reportable event.Please see block h11 for investigation results.

• 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: 24023222
• Report Number: 3005099803-2026-00135
• Device Sequence Number: 15737333
• Product Code: FDI
• UDI-Device Identifier: 08714729158158
• UDI-Public: (01)08714729158158
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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