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

Model Number M00562670

Device Problems Failure to Deliver Energy (1211); Failure to Cut (2587)

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

Event Date 03/24/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a sensation medium oval was used for polypectomy during a colonoscopy procedure performed on (b)(6) 2022.During the procedure and inside the patient, the snare was used to attempt to cut through a polyp; however, the snare did not generate any current and the snare wire was too weak to cut without current.The snare was unplugged from the cautery cord and was re-plugged, and all cords and settings to the cautery machine were checked.The snare was securely attached to the active cord and there was no problem noted with the cautery pin.There were no signs of blanching.The snare was removed from the patient and the procedure was completed with another sensation medium oval.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Imdrf device code a050702 captures the reportable event of snare loop too weak to cut.

• 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16709869
• MDR Text Key: 312987452
• Report Number: 3005099803-2023-01870
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729748083
• UDI-Public: 08714729748083
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562670
• Device Catalogue Number: 6267S
• Device Lot Number: 0028315882
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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