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

Model Number	M00561103
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Section e: this event was reported by the sales representative.The healthcare facility is: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of loop broken.
Event or Problem Description
It was reported to boston scientific corporation that a cold snare was used in the colon during a colonoscopy.The exact procedure date was unknown.It was reported that the wire snapped during polyp removal.The procedure was completed, although there was no information regarding which device was used to finish the case.The patient subsequently underwent an mri, and the scope involved in the event is currently being repaired.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Section e: this event was reported by the sales representative.The healthcare facility is: (b)(6).Phone: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of loop broken.Block h11: investigation result the device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device, however response was not received.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.Based on the event description and information provided by the customer there is not enough evidence to determine whether the reported events were due to the physician's technique during the procedure or were related to a device malfunction.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a cold snare was used in the colon during a colonoscopy.The exact procedure date was unknown.It was reported that the wire snapped during polyp removal.The procedure was completed, although there was no information regarding which device was used to finish the case.The patient subsequently underwent an mri, and the scope involved in the event is currently being repaired.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• 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: 24717368
• Report Number: 3005099803-2026-01130
• Device Sequence Number: 5763247
• Product Code: FGX
• UDI-Device Identifier: 08714729984986
• UDI-Public: (01)08714729984986(17)281110(10)37934912
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: 0037934912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/22/2026
• Date Device Manufactured: 11/11/2025
• 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