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

Model Number	M00561291
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Cut (2587); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of snare loop unable to cut.Imdrf impact code f08 captures the reportable event of prolonged hospitalization.Imdrf impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used in the terminal ileum to remove a 27 mm polyp during a colonoscopy procedure performed on (b)(6) 2025.During the procedure and inside the patient, the scope was in an awkward position with looping, complicating access.The polyp was successfully lifted and prepared for resection using a snare device.However, the snare became entangled in the polyp and could not be disengaged.Upon inspection, the snare wire was found to be twisted near the base and was unable to cut through despite diathermy application.A second endoscopist was called to assist.After multiple unsuccessful attempts, the snare was manually cut with scissors, and the scope was withdrawn with the plastic snare component removed.The endoscope was reinserted with biopsy forceps to release the remaining snare.By this time, the polyp had migrated into the colon.A portion was removed, and the remainder fell back into the terminal ileum.The team was eventually able to complete the polypectomy, although not all fragments were retrieved, only the portion that had entered the colon.The patient experienced discomfort post-procedure and was advised to remain in the ward for two hours for observation.A follow-up rescope with polypectomy (4 points) is scheduled in three months.The snare was securely attached to the active cord and no visible problem was noted with the cautery pin.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22743398
• Report Number: 3005099803-2025-03917
• Device Sequence Number: 20929143
• Product Code: FDI
• UDI-Device Identifier: 08714729645801
• UDI-Public: (01)08714729645801(17)271022(10)35124032
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 08/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00561291
• Device Catalogue Number: 6129
• Device Lot Number: 0035124032
• 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: 07/21/2025
• Initial Report FDA Received Date: 08/07/2025
• Date Device Manufactured: 10/22/2024
• 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 Age: 69 YR
• Patient Sex: Male