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

Model Number	M00562690
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Entrapment of Device (1212); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150208 captures the reportable event of snare loop entrapment.Imdrf device code a050702 captures the reportable event of snare loop cutting problems.Imdrf device code a07 captures the reportable event of snare delivers energy intermittently.
Event or Problem Description
It was reported to boston scientific corporation that a sensation short throw snare was used to remove polyps during a polypectomy procedure performed on (b)(6) 2023.During the procedure and inside the patient, the snare did not cut a large 2cm pedunculated polyp.The nurse reported that the cautery was working but it did not show that it was cutting through on the screen.It showed no change in color of tissue and the nurse said that it didn't bubble up.The cautery machines and pedals were switched but still it was unsuccessful.The snare loop was embedded in the tissue, and after 10-15 minutes of attempting to remove the snare from the long polyp without success, the snare was repositioned and cautery was attempted again and the snare was able to cut through the polyp successfully.The procedure was completed with the original device.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 DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18784358
• Report Number: 3005099803-2024-00547
• Device Sequence Number: 12720965
• Product Code: FDI
• UDI-Device Identifier: 08714729748106
• UDI-Public: 08714729748106
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K941750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/26/2024

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: 11/10/2025
• Device Model Number: M00562690
• Device Catalogue Number: 6269S
• Device Lot Number: 0030525338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• 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