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

Model Number	M00561221
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator was intended to be used in the colon during a polypectomy procedure performed on 22 june 2026.During insertion, the snare device had poor energization.The procedure was completed with an alternative device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a07 captures the reportable event of device electrical /electronic property problem.Block h3: the device was returned for analysis; however, the investigation is still in progress.A supplemental report will be submitted when the investigation is complete or if additional relevant information becomes available.

• 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: 25882193
• Report Number: 3005099803-2026-02948
• Device Sequence Number: 20833439
• Product Code: FDI
• UDI-Device Identifier: 08714729855903
• UDI-Public: (01)08714729855903(17)281108(10)37915723
• 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): 08/24/2026

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: 0037915723
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/03/2026
• 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: 06/23/2026
• Supplement Date Received by Manufacturer: 07/26/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2025
• 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