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

Lot Number 30525338

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/20/2023

Event Type  malfunction  

Event Description

Potentially defective boston scientific sensation short throw snare, lot 30525338, exp: 11-10-2025.Initially the snare would not cut or coagulate for polypectomy on a large 2cm pedunculated/pendulous polyp.The intraop rn said that it sounded like the cautery was working but did not show that it was cutting through on the screen- "didn't even bubble up the tissue" and no change in color of tissue.They switched out cautery machines/pedals and it was still unsuccessful.After 10-15 minutes and then trying to get the snare off the long polyp since it was then embedded in the tissue, they tried to reposition, attempted cautery again and were then able to cut through the polyp successfully.

• Brand Name: SENSATION SHORT THROW SNARE
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18464130
• MDR Text Key: 332436845
• Report Number: MW5149903
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 30525338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1