MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II; snare, flexible

Model Number	M00561231
Medical Device Problem Codes	Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used for a cold polypectomy procedure performed on (b)(6) 2026.During the procedure the snare failed to cut easily the target polyp.Procedure was completed with heat added to the original device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of loop failure to cut.

• Brand Name: CAPTIVATOR II
• Common Device Name: 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25738468
• Report Number: 3005099803-2026-02702
• Device Sequence Number: 21453676
• Product Code: FDI
• UDI-Device Identifier: 08714729855910
• UDI-Public: (01)08714729855910(17)290107(10)38292978
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00561231
• Device Catalogue Number: M00561231
• Device Lot Number: 0038292978
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Supplement Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown