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

Model Number	M00562422
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
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 captiflex 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 event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications.Upon analysis, there is insufficient evidence to determine whether the issue resulted from the physician's technique during the procedure or from a device malfunction.Additionally, based on the key complaint information and the product record review, the device met all required manufacturing specifications, passed all controls and inspections, and showed no abnormalities during assembly; however, the definitive cause of the reported issue cannot be determined due to insufficient evidence.Without a proper evaluation of the device, the factors that contributed to the event 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 captiflex - snares was used in the colon during a colonoscopy procedure performed on (b)(6) 2026.During the procedure, the physician tried to cut the polyp cold and the snare was unable to cut cold.The procedure was completed, but there was no information regarding which device was used to finish it.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIFLEX
• 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: 24588963
• Report Number: 3005099803-2026-00944
• Device Sequence Number: 20256109
• Product Code: FDI
• UDI-Device Identifier: 08714729501657
• UDI-Public: (01)08714729501657(17)280707(10)36918753
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 03/13/2026

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: M00562422
• Device Catalogue Number: 6242-40
• Device Lot Number: 0036918753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/13/2026
• Date Device Manufactured: 07/08/2025
• 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