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

Model Number	M00562692
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a07 captures the reportable event of the device delivering energy intermittently.Imdrf device code a0501 captures the reportable event of the cautery pin detached.
Event or Problem Description
Note: this report pertains to the first of three sensation short throw snares used during the same procedure.It was reported to boston scientific corporation that a sensation short throw snare was used in the stomach during a polypectomy procedure for polyps performed on (b)(6) 2024.During the procedure, it was noted that there was no energy from the erbe machine as the doctor stepped on the pedal.The physician tried several times and was unable to commence polypectomy.The physician tried to reposition snare, but the results are similar.Two other devices were used with the same result.The procedure was completed with a similar sensation short throw snare.There were no patient complications reported as a result of this event.
Event or Problem Description
Note: this report pertains to the first of three sensation short throw snares used during the same procedure.It was reported to boston scientific corporation that a sensation short throw snare was used in the stomach during a polypectomy procedure for polyps performed on (b)(6) 2024.During the procedure, it was noted that there was no energy from the erbe machine as the doctor stepped on the pedal.The physician tried several times and was unable to commence polypectomy.The physician tried to reposition snare, but the results are similar.Two other devices were used with the same result.The procedure was completed with a similar sensation short throw snare.There were no patient complications reported as a result of this event.Additional information received on january 17, 2025.The connector pin fit very loosely with the erbe banana plug, and it was not detached.
Additional Manufacturer Narrative
Block h6: imdrf device code a07 captures the reportable event of the device delivering energy intermittently.Imdrf device code a0501 captures the reportable event of the cautery pin detached.Block h2: additional information: block b5 (describe event or problem) and block h6 (device code) have been updated based on the additional information received on january 17, 2025.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21105162
• Report Number: 3005099803-2024-06850
• Device Sequence Number: 8067868
• Product Code: FDI
• UDI-Device Identifier: 08714729268826
• UDI-Public: 08714729268826
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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 Expiration Date: 09/25/2026
• Device Model Number: M00562692
• Device Catalogue Number: 6269-20
• Device Lot Number: 0032513126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/13/2025
• Date Device Manufactured: 09/26/2023
• 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