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

Model Number	M00561221
Medical Device Problem Codes	Break (1069); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e: this event was reported by the sales representative.The healthcare facility is: (b)(6).Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.Imdrf device code a0401 captures the reportable event of loop broken.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snares was used in the colon during a colonoscopy procedure performed on (b)(6) 2026.It was reported that the snares were initially unable to fully cut the polyp, and when they eventually did, the snare wire broke.The procedure was then completed using another captivator ii snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Section e: this event was reported by the sales representative.The healthcare facility is: (b)(6).Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.Imdrf device code a0401 captures the reportable event of loop broken.Block h11: the returned captivator ii was analyzed, and upon visual inspection, no visible damage was observed.During functional testing, the device was extended and retracted in the 10-inch loop fixture, and the loop extended properly without any issues.The loop was also confirmed to be intact.Additionally, continuity and electrical testing were performed, and the device was found to be within specification.No other problems with the device were noted.The reported event of snare loop cutting problems and loop broken were not confirmed.It was confirmed that the loop was able to extend and retract properly in the 10-inch loop fixture.The continuity and electrical tests performed on the device were also found to be within specifications.However, the device cannot be functionally tested in a manner that fully emulates the anatomical or procedural conditions encountered during the actual procedure.Based on all available information, the probable root cause assigned is unable to exclude device problem.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snares was used in the colon during a colonoscopy procedure performed on (b)(6) 2026.It was reported that the snares were initially unable to fully cut the polyp, and when they eventually did, the snare wire broke.The procedure was then completed using another captivator ii snare.There were no patient complications reported as a result of this event.

• 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: 24209150
• Report Number: 3005099803-2026-00351
• Device Sequence Number: 5430798
• Product Code: FDI
• UDI-Device Identifier: 08714729855903
• UDI-Public: (01)08714729855903(17)280804(10)37135387
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: M00561221
• Device Catalogue Number: 6122
• Device Lot Number: 0037135387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2025
• 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