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

Model Number	M00562693
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a sensation small oval flexible snare was used during a colonoscopy procedure for polypectomy performed on (b)(6) 2025.During the procedure, the handpiece that the technician was holding, to which the cautery cord was attached, was getting very hot.It appeared that the cautery electrodes were not functioning as they should.The procedure was completed with another sensation small oval flexible snare device.There were no patient complications reported as a result of this event.No further information has been obtained despite good-faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a07 captures the reportable event of the device delivering energy intermittently.
Additional Manufacturer Narrative
Block h2 (additional information): block b5 has been updated based on the additional information received on april 15, 2025.Block h6: imdrf device code a07 captures the reportable event of the device delivering energy intermittently.
Event or Problem Description
It was reported to boston scientific corporation that a sensation small oval flexible snare was used during a colonoscopy procedure for polypectomy performed on (b)(6) 2025.During the procedure, the handpiece that the technician was holding, to which the cautery cord was attached, was getting very hot.It appeared that the cautery electrodes were not functioning as they should.The procedure was completed with another sensation small oval flexible snare device.There were no patient complications reported as a result of this event.Additional information received on april 15, 2025: the anatomy location is in the left lateral colon.

• 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: 21769861
• Report Number: 3005099803-2025-01410
• Device Sequence Number: 9821968
• Product Code: FDI
• UDI-Device Identifier: 08714729501671
• UDI-Public: (01)08714729501671(17)271219(10)35522155
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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 Model Number: M00562693
• Device Catalogue Number: 6269-40
• Device Lot Number: 0035522155
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/09/2025
• Date Device Manufactured: 12/19/2024
• 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