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

Model Number M00562672

Device Problems Entrapment of Device (1212); Failure to Cut (2587)

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

Event Date 06/15/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a150208 captures the reportable event of loop entanglement within the patient's tissue.Imdrf device code a050702 captures the reportable event of loop cutting issue.

Event Description

It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, three different physicians from three separate procedures were attempting to remove a large polyp with a snare, but encountered difficulties.The snare became stuck while trying to cut through the polyp, making it impossible to cauterize it.Despite their efforts, they were unable to remove the snare and had to resort to cutting off the plastic sheath using pliers and then utilized a 15mm captivator ii snare to remove the remaining parts of the polyp in small pieces, dislodging the original snare.This occurred with two separate batches of the same snare.The procedure was completed with a captivator ii snare.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: 17577521
• MDR Text Key: 321512454
• Report Number: 3005099803-2023-04223
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729268819
• UDI-Public: 08714729268819
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562672
• Device Catalogue Number: 6267-20
• Device Lot Number: 0027991426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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
• Patient Outcome(s): Required Intervention