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

Model Number	M00561100
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that a captivator cold snare was used in the colon for a polypectomy procedure performed on (b)(6) 2026.During the procedure, the captivator cold snare failed to cut the polyp.Another unknown alternative method was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Imdrf device code a050702 captures the reportable event of device failure to cut.Device evaluation: the device was not returned for analysis; therefore, a technical analysis could not be performed.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.A risk review was completed and confirmed that the event of "loop failure to cut" was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the event description and information provided by the customer there is not enough evidence to determine whether the issue was induced due to the physician's technique during the procedure or was related to a device malfunction, "unable to exclude device problem" is selected as the most probable cause for this event.All compiled information on this investigation determines that the most probable cause is "unable to exclude device problem".No further escalation is required.

• Brand Name: CAPTIVATOR? COLD
• Common Device Name: SNARE, NON-ELECTRICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: christina lam lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24605980
• Report Number: 3005099803-2026-00902
• Device Sequence Number: 18734901
• Product Code: FGX
• UDI-Device Identifier: 08714729971252
• UDI-Public: (01)08714729971252
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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: M00561100
• Device Catalogue Number: M00561100
• 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: 02/24/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown