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

Model Number	M00561233
Medical Device Problem Codes	Failure to Deliver Energy (1211); 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	06/17/2025
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 transverse colon to remove a less than 1cm sessile polyp during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, the snare was passed through the scope and was securely connected to the active cable.However, when cautery was engaged, the snare was unable to cut, and coagulation would not work.No visible problem was noted with the cautery pin.The 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 a050702 captures the reportable event of snare loop unable to cut.Imdrf device code a090402 captures the reportable event of snare unable to deliver energy.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used in the transverse colon to remove a less than 1cm sessile polyp during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, the snare was passed through the scope and was securely connected to the active cable.However, when cautery was engaged, the snare was unable to cut, and coagulation would not work.No visible problem was noted with the cautery pin.The 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 a050702 captures the reportable event of snare loop unable to cut.Imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Block h10: investigation results: a captivator ii-15mm round stiff snare was received for analysis.Visual inspection of the returned device revealed the working length and wire were kinked at proximal section (strain relief).Functional inspection was performed and when the device was connected to the 10 inch loop fixture, the loop could extend completely.Electrical and continuity testing were performed, and the device was found within specification.No other problems were noted.The reported complaint of loop failure to cut and device failure to deliver energy were unable to be confirmed since the device passed electrical testing upon return.Upon product analysis it was found that the working length and wire were kinked at proximal section (strain relief).These problems likely occurred due to the way the device was handled and manipulated.Improper or excessive handling without sufficient care may have contributed to the defects that were reported and observed.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.

• 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 ; 9145716918
• MDR Report Key: 22926497
• Report Number: 3005099803-2025-04132
• Device Sequence Number: 9107395
• Product Code: FDI
• UDI-Device Identifier: 08714729861348
• UDI-Public: (01)08714729861348(17)270306(10)33571940
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133987
• 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): 10/14/2025

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: M00561233
• Device Catalogue Number: 50297
• Device Lot Number: 0033571940
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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