MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II; SNARE, FLEXIBLE

Model Number M00561223

Device Problem Failure to Cut (2587)

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

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the physician initially attempted to use a hot snare for a procedure, but it was unsuccessful in cutting through the tissue.They then tried using a different snare using cold polypectomy, but it also unsuccessful in cutting through the tissue.It was not reported what device was used to complete the procedure there were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the physician initially attempted to use a hot snare for a procedure, but it was unsuccessful in cutting through the tissue.They then tried using a different snare using cold polypectomy, but it also unsuccessful in cutting through the tissue.It was not reported what device was used to complete the procedure.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 loop cutting issue.Block h10: investigation results: a captivator snare was received for analysis.Visual analysis of the returned device found no device problems.Functional evaluation of the returned device found that when the device was connected to the 10 inch loop fixture, it contracted and extended well.Continuity test was also performed and the device's electrical resistance was within specification.No other device problems were noted.The reported event of "loop failure to cut" could not be confirmed since the device cannot be functionally evaluated with respect to the anatomical/procedural factors encountered during the procedure.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Device analysis found no problems with the device during visual, functional and continuity test.Based on the analysis of the returned device and the information available, the code selected as the most probable root cause is no problem detected.This code was selected since the reported event could not be confirmed.

• Brand Name: CAPTIVATOR II
• 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: 17202679
• MDR Text Key: 318238346
• Report Number: 3005099803-2023-03304
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729861317
• UDI-Public: 08714729861317
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133987
• 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,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561223
• Device Catalogue Number: 50297
• Device Lot Number: 0031557016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1