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

Model Number	M0056471
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a040 captures the reportable event of break.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex oval flexible snare was used during a colonoscopy procedure on (b)(6) 2026.During the procedure, there were a couple snares that malfunction when trying to cut a polyp.The snares would either not cut all the way and the wire would break away from the handle.There were no patient complications reported as a result of this event.This report pertains to one of the two devices used during the procedure; this entry specifically refers to the first device, which corresponds to the failure mode "snare wire broke".
Event or Problem Description
It was reported to boston scientific corporation that a captiflex oval flexible snare was used during a colonoscopy procedure on (b)(6) 2026.During the procedure, there were a couple snares that malfunction when trying to cut a polyp.The snares would either not cut all the way and the wire would break away from the handle.There were no patient complications reported as a result of this event.This report pertains to one of the two devices used during the procedure; this entry specifically refers to the first device, which corresponds to the failure mode "snare wire broke".Additional information received on (b)(6) 2026 and (b)(6) indicates that a rescuenet was used to retrieve the detached piece.
Additional Manufacturer Narrative
Block h6: imdrf device code a040 captures the reportable event of loop break.Additional information: block b5: describe event or problem has been updated based on the additional information received on march 9th, 2026.Block h2: corrections: d4 (model number), d5 (operator of device and operator of device, other), block e1 (initial reporter information).Investigation results: the device was returned, and it was found during visual inspection that the flare was detached from the working length (strain relief) and handle, and the wire was kinked at the proximal section.During microscopic inspection it was found that the working length had evidence of the flare being made.Based on the evidence, the reported event of loop break was unable to be confirmed.The investigation results summary did not detect any problems related to the reported issue, loop break as the loop was found not to be broken.Therefore, no problem detected was chosen as the analyzed cause code for this failure.However, during product analysis, it was found that the flare was detached from the working length (strain relief) and handle, and the wire was kinked.It is likely that this failure could be due to excessive manipulation during the procedure, for this reason, this failure will be concluded as adverse event related to procedure.It was confirmed this device met manufacturing specifications prior to distribution, and there were no manufacturing deviations that could have contributed to the reported event.Based on the analysis performed and all the information gathered from the customer, the overall conclusion code assigned will be "adverse event related to procedure".

• 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: 24531280
• Report Number: 3005099803-2026-00850
• Device Sequence Number: 21100025
• Product Code: FDI
• UDI-Device Identifier: 08714729019459
• UDI-Public: (01)08714729019459(17)281110(10)37906982
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: M0056471
• Device Catalogue Number: 6247
• Device Lot Number: 0037906982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2025
• 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