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

Model Number	M00561103
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e: this event was reported by the sales representative.The health care facility is: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of loop break.Block h11: investigation results the complaint device was not returned; therefore, for this reason and due to the lack of evidence is unable to confirm the reported event.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Because the device was unavailable for testing and there is insufficient information to determine whether the issue was related to procedural technique or a potential device malfunction.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.
Event or Problem Description
It was reported to boston scientific corporation that a captivator cold single-use snare was used during a colonoscopy for the treatment of polyps, on (b)(6) 2026.During the procedure, the loop snapped.The procedure was completed with another captivator cold single-use snare.There were no patient complications reported as a result of this event.

• 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: 24619284
• Report Number: 3005099803-2026-00991
• Device Sequence Number: 9640114
• Product Code: FGX
• UDI-Device Identifier: 08714729984986
• UDI-Public: (01)08714729984986(17)281028(10)37824086
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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: 0037824086
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/17/2026
• Date Device Manufactured: 10/29/2025
• 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