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

Model Number	M00562301
Medical Device Problem Codes	Break (1069); 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	01/07/2026
Type of Reportable Event	Malfunction
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.
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 snares was analyzed, and visual as well as microscopic inspection revealed that the flare was detached from both the working length (strain relief) and the handle.Under magnification, it was also noted that the working length showed evidence indicating that the flare had previously been formed.The loop was confirmed to be intact.Continuity and electrical testing were conducted, and the device was found to be within specification.Finally, the device was tested using the erbe (bsc0077509), and no issues in delivering energy to the snare.No other problems with the device were noted.The reported event of snare loop cutting problems and loop broken were not confirmed.It was found that the device had a detached flare from both the working length (strain relief) and the handle.The condition of the flare suggests that it had been manipulated.This most likely occurred due to the manner in which the device was handled and manipulated, which may have contributed to both the reported and observed issues.Excessive or improper manipulation of the device could have induced the defect identified during the investigation.It was determined that the continuity and electrical tests conducted on the device were within the required specifications.Additionally, the devices cannot be functionally tested under conditions that emulate the anatomical or procedural factors encountered during actual use.Based on all available information, the probable root cause assigned is adverse event related to procedure.
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
• 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: 24209420
• Report Number: 3005099803-2026-00352
• Device Sequence Number: 5458444
• Product Code: FDI
• UDI-Device Identifier: 08714729019312
• UDI-Public: (01)08714729019312(17)280622(10)36814952
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• 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: M00562301
• Device Catalogue Number: 6230
• Device Lot Number: 0036814952
• 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: 03/09/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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