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

Model Number	M00561103
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of loop detachment.Investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.During the media inspection of the picture attached it was possible to observe the loop detached.Based on this evidence the reported event of "loop detachment of device or device component" can be confirmed.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, information and picture 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 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 that a cold snare was used for a polyp removal, during a colonoscopy procedure performed on (b)(6) 2026.During the procedure, the snare loop detached from the device.The loop was removed from the patient with the same device.The procedure was completed with another snare.There were no patient complications 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: 25356317
• Report Number: 3005099803-2026-02250
• Device Sequence Number: 10653838
• Product Code: FGX
• UDI-Device Identifier: 08714729984986
• UDI-Public: (01)08714729984986(17)281115(10)37970493
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: 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: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: 0037970493
• 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: 05/07/2026
• Initial Report FDA Received Date: 06/01/2026
• Date Device Manufactured: 11/16/2025
• 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