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

Model Number	M00561100
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Cut (2587); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complaint was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a050702 captures the reportable event of device failure to cut.It is unclear what lot number was used for this procedure since the event stated that lot 37526942 and 36205499 may have been used.
Event or Problem Description
It was reported to boston scientific that a cold snare was used for a polypectomy procedure performed on an unknown date.During the procedure when advancing and retracting, the snare would not respond properly, it did tend to get stuck and the cutting performance was not effective.Unknown how procedure was completed.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific that a cold snare was used for a polypectomy procedure performed on an unknown date.During the procedure when advancing and retracting, the snare would not respond properly, it did tend to get stuck and the cutting performance was not effective.Unknown how procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complaint was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a050702 captures the reportable event of device failure to cut.Device evaluation.The device was not returned for analysis; therefore, a product analysis could not be performed.During the media inspection it was found that the pictures provided were not related to the reported issue.A device history record review was performed based in the two batches/lots reported (37526942 - 36205499).It was confirmed this device met manufacturing specifications 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.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A labeling review was performed.The instructions for use (ifu) contain detailed device information and instructions for the device use.There is no evidence that the device was improperly used per the ifu, and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on the event description, information and photos provided by the customer there is not enough evidence to determine whether the issues were induced by the physician technique during the procedure or it was related to a device malfunction.Therefore, these issues will be classified "cause not established".

• Brand Name: Captivator¿ COLD
• 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: 25191494
• Report Number: 3005099803-2026-01925
• Device Sequence Number: 13345537
• Product Code: FGX
• UDI-Device Identifier: 08714729971252
• UDI-Public: (01)08714729971252
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Supplement Date Received by Manufacturer: 06/22/2026; 07/31/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 07/14/2026; 08/28/2026
• 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