MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II; snare, flexible

Model Number	M00561231
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used in the ascending colon during a colonoscopy procedure performed on (b)(6) 2026.During the procedure, the physician was able to cold cut a pedunculated polyp.After that, the device was unable to deliver heat when soft coagulation was attempted to cauterize the polyp site.As a result, clips were placed to stop the bleeding at polyp site.Procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of device failure to deliver energy.Device evaluation: the device did not return for analysis; therefore, a technical analysis could not be performed.A review was completed of the device history records (dhr) for the device.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 issue was induced due to the physicians technique during the procedure or was related to a device malfunction.A labeling review was performed using windchill.The ifu contains detailed device information and instructions for the device use.Additionally, it was confirmed that the following adverse event are anticipated in the ifu: hemorrhage, minor (hemorrhage).Also, there is no evidence 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.For this reason, the event of minor hemorrhage was classified as known inherent risk of device.Additionally, based on the most relevant information for the complaint including product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process, the definitive cause of the reported issue cannot be established due to lack of evidence.Without proper evaluation of the device, it remains unknown the causes that contributed to the event.Based on all gathered information, the probable cause selected is cause not established.

• Brand Name: CAPTIVATOR II
• 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 ; +1(914)571-6918
• MDR Report Key: 25673471
• Report Number: 3005099803-2026-02626
• Device Sequence Number: 18753980
• Product Code: FDI
• UDI-Device Identifier: 08714729855910
• UDI-Public: (01)08714729855910(17)281218(10)38224100
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133987
• 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
• Report Date (Section B): 08/05/2026

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: M00561231
• Device Catalogue Number: M00561231
• Device Lot Number: 0038224100
• 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: 06/03/2026
• Supplement Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 08/05/2026
• Date Device Manufactured: 12/19/2025
• 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