MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Captivator COLD Single-use snare; Snare, Non-Electrical

Model Number	M00561101
Medical Device Problem Codes	Mechanical Problem (1384); Retraction Problem (1536); Failure to Cut (2587); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
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 in the colon for a colonic polypectomy procedure performed on an unknown date.During the procedure the snare was stiff when opening and closing and could not cut the polyp.The procedure was completed with another of the same device.There were no patient complications 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 a050702 captures the reportable event of loop failure to cut.

• 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 ; +1(914)571-6918
• MDR Report Key: 50196983
• Report Number: 3005099803-2026-03250
• Device Sequence Number: 10274293
• Product Code: FGX
• UDI-Device Identifier: 08714729971269
• UDI-Public: (01)08714729971269(17)280616(10)36779246
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: Exempt
• 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): 09/02/2026

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: M00561101
• Device Catalogue Number: M00561101
• Device Lot Number: 0036779246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2026
• Supplement Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 06/17/2025
• 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