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

Model Number	6129
Medical Device Problem Codes	Failure to Cut (2587); Defective Device (2588); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of snare loop unable to cut.Imdrf device code f1001captures the reportable event of cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used in the sigmoid colon during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, the physician used the captivator to resect a large pedunculated polyp but the wire closest to the base or the scope handle was bent and twisted when the snare was in tightened close to its maximum and eventually burnt the plastic covering of the snare.In addition, the polyp removal was unsuccessful.The procedure was rescheduled.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported that during the procedure, the physician used the captivator to resect a large a polyp in the sigmoid colon but the wire closest to the base or the scope handle was bent and twisted when the snare was in tightened close to its maximum and eventually burnt the plastic covering of the snare.In addition, the polyp removal was unsuccessful.The procedure was rescheduled.
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of snare loop unable to cut.Imdrf device code f1001 captures the reportable event of cancelled procedure.Block h11: investigation results.The captivator ii device was not returned as it was reported to be disposed.A technical analysis could not be performed.However, a media analysis was performed on the photos provided by the complainant where it can be observed that the working length was bent or kink.No other problems with the device were noted.According to the media analysis performed, it was possible to observe that the working length was kinked, however, the most probable cause of the reported event of snare loop unable to cut cannot be established due to lack of evidence.The product was not returned for analysis as it was reported to be disposed, and a technical analysis could not be performed.The investigation concluded that, without analysis of the device, the most probable root cause of the clinical observations 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 ; 9145716918
• MDR Report Key: 23181970
• Report Number: 3005099803-2025-04918
• Device Sequence Number: 10074670
• Product Code: FDI
• UDI-Device Identifier: 08714729645801
• UDI-Public: (01)08714729645801(17)280401(10)36214734
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K202478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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: 6129
• Device Catalogue Number: 6129
• Device Lot Number: 0036214734
• 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: 09/08/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 10/27/2025
• Date Device Manufactured: 04/02/2025
• 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