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

Model Number M00562670

Device Problems Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.

Event Description

It was reported to boston scientific corporation that a sensation short throw snare was used during a colonoscopy procedure performed on (b)(6) , 2023.During the procedure, the device was passed through the scope and was opened and closed a few times, but the device would not cut through the polyp.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results: a sensation snare was received for analysis, and it was found that the working length was detached.In the other hand, the flare was noted kinked.Due to this condition, it was unable to perform a functional inspection.No problems were noted.The reported complaint of snare failure to cut was unable to be confirmed.Investigation found that the working length was detached.Also, the flare was kinked.Due to this condition, it was unable to perform a functional inspection to verify if the loop was able to extend and retract correctly.It is possible that this could happened because as part of the device manipulation during preparation, an excess of force was applied in order to get the device out of the package, causing the working length to get detached.Also, possibly during its actuation during the testing the analyzed damages could have been caused.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected since product analysis of the returned device and product record review did not identify any evidence of either the alleged problem(s) or any defect on the device.

Event Description

It was reported to boston scientific corporation that a sensation short throw snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the device was passed through the scope and was opened and closed a few times, but the device would not cut through the polyp.The procedure was completed with another of the same 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 CORPORATION; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18764219
• MDR Text Key: 336970061
• Report Number: 3005099803-2024-00586
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• 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: 0031105441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2023
• 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