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

Model Number	M00562321
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Cut (2587); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.Block h11: the captivator - snares was not returned; therefore, product analysis could not be performed, for this reason and due to the lack of evidence is unable to confirm the reported events.Upon analysis, there is insufficient evidence to determine whether the issues resulted from the physician's technique during the procedure or from a device malfunction.Additionally, based on the most relevant information for the complaint including the product record review results, the device met all required manufacturing specifications and passed all controls and inspections, with no abnormalities reported during assembly.Due to insufficient evidence, the definitive cause of the reported issues cannot be established.Without the device, the factors that contributed to the events remain unknown.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 - snares was used in the colon during a colonoscopy procedure performed on (b)(6) 2026.It was reported that the cable was connected to the snare and cautery was applied to cut through the polyp.When they observed that the cut was not progressing fully, they stopped the cautery and inspected the device, noting that the plastic sheath had slightly melted.The procedure was completed with another captivator - snares.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: 24580871
• Report Number: 3005099803-2026-00920
• Device Sequence Number: 13351085
• Product Code: FDI
• UDI-Device Identifier: 08714729019336
• UDI-Public: (01)08714729019336(17)280626(10)36856604
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2026

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: M00562321
• Device Catalogue Number: 6232
• Device Lot Number: 0036856604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/12/2026
• Date Device Manufactured: 06/27/2025
• 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