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	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cold snare was used during a colonoscopy procedure performed on an unknown date.During the procedure, the snare loop was unable to cut the polyp.Additional force on the handle was used to close the snare, but the poly was still not able to be cut.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.Device evaluation.The device was not returned for analysis; therefore, a technical analysis could not be performed.A device history record review was performed.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.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 and information provided by the customer there is not enough evidence to determine whether the issue was induced by the physician technique during the procedure or it was related to a device malfunction, "cause not established" is selected as the most probable cause for this event.All compiled information on this investigation determines that the most probable cause is 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: 50803545
• Report Number: 3005099803-2026-03831
• Device Sequence Number: 10589731
• Product Code: FGX
• UDI-Device Identifier: 08714729971252
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 09/17/2026

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: M00561100
• Device Catalogue Number: M00561100
• Device Lot Number: 0038940569
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 03/26/2026
• 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