MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR; SNARE, FLEXIBLE

Model Number	M00562451
Medical Device Problem Codes	Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event loop-cutting problem.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare device was used during an endoscopic mucosal resection (emr) procedure for large polyp removal performed on (b)(6) 2025.During the procedure, the snare was activated but did not cut through the tissue.The procedure was successfully completed using another captivator snare device.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 h6: imdrf device code a050702 captures the reportable event loop-cutting problem.Block h11: a captivator snare was received for analysis.Visual inspection identified that the working length and wire were kinked.A continuity and electrical test were performed, and the device was found within specification.No other problems with the device were noted.The reported complaint of snare failure to cut was not confirmed.Investigation found that the working length and wire were kinked.It is possible that operational factors such as the size of the polyp and the force applied to the device in order to remove the tissue, could have caused or contributed to the reported allegation.The force applied to the handle in order to actuate the device, could generate tension forces on the distal section of the device that are transmitted to the proximal section (handle), causing the bent of the handle cannula.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare device was used during an endoscopic mucosal resection (emr) procedure for large polyp removal performed on (b)(6) 2025.During the procedure, the snare was activated but did not cut through the tissue.The procedure was successfully completed using another captivator snare device.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
• Common Device Name: SNARE, FLEXIBLE
• 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: 23757831
• Report Number: 3005099803-2025-06647
• Device Sequence Number: 13245315
• Product Code: FDI
• UDI-Device Identifier: 08714729071068
• UDI-Public: (01)08714729071068(17)280127(10)35714446
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: M00562451
• Device Catalogue Number: 6245
• Device Lot Number: 0035714446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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