MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR COLD SINGLE-USE SNARE; SNARE, NON-ELECTRICAL

Model Number	M00561103
Medical Device Problem Codes	Retraction Problem (1536); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator cold single-use snare was used during a polyp retrieval procedure on (b)(6) 2026.During the procedure, it was difficult to close the snare slowly around the polyp.The snare closed rapidly, resulting in inadvertent cutting of the polyp.The polyp was retrieved, but not in the manner the physician intended.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0510 captures the reportable event of retracted suddenly/unexpectedly.

• Brand Name: CAPTIVATOR COLD SINGLE-USE SNARE
• Common Device Name: SNARE, NON-ELECTRICAL
• 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 ; 9145716918
• MDR Report Key: 24381411
• Report Number: 3005099803-2026-00638
• Device Sequence Number: 10185265
• Product Code: FGX
• UDI-Device Identifier: 08714729984986
• UDI-Public: (01)08714729984986(17)280807(10)37164638
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: 510K EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: M00561103
• Device Catalogue Number: M00561103
• Device Lot Number: 0037164638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2025
• 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