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

Model Number M00562690

Device Problems Electrical /Electronic Property Problem (1198); Entrapment of Device (1212); Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 336405402
• Report Number: 3005099803-2024-00547
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1