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

Model Number	M00561221
Medical Device Problem Codes	Failure to Cut (2587); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of loop failure to cut.
Event or Problem Description
It was reported to boston scientific that a captivator snare was used in the colon for a colonoscopy procedure performed on (b)(6) 2026.During the procedure the snare presented more friction than usual and could not make a clean cut.The procedure was completed with the original device.There were no patient complications as a result of this event.

• 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 ; EI 01752 ; 9145716918
• MDR Report Key: 25536464
• Report Number: 3005099803-2026-02505
• Device Sequence Number: 9395068
• Product Code: FDI
• UDI-Device Identifier: 08714729855903
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Followup
• Report Date (Section B): 09/01/2026

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: M00561221
• Device Catalogue Number: M00561221
• Device Lot Number: 0038856607
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• 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: 05/26/2026
• Supplement Date Received by Manufacturer: 06/19/2026; 08/06/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 07/14/2026; 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2026
• 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