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

Model Number	M00562471
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captiflex snare was used during a polyp removal procedure performed on (b)(6) 2025.During the procedure, it a failure of cautery during an attempt to hot snare a large sigmoid polyp.11mm extra small oval flexible snare was being used and was hooked up to the cautery machine.Cautery would work intermittently, not cauterizing all the way through the colon polyp.The connection between the snare and the cautery cord seemed to not be tight once clicked in.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a07 captures the reportable event of snare device delivers energy intermittently.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex snare was used during a polyp removal procedure performed on (b)(6) 2025.During the procedure, it a failure of cautery during an attempt to hot snare a large sigmoid polyp.11mm extra small oval flexible snare was being used and was hooked up to the cautery machine.Cautery would work intermittently, not cauterizing all the way through the colon polyp.The connection between the snare and the cautery cord seemed to not be tight once clicked in.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a07 captures the reportable event of snare device delivers energy intermittently.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of device delivers energy intermittently.The returned captiflex snare was analyzed, and no damage was observed.The device was subjected to functional testing, and the loop extended properly without any issues.Additionally, the continuity and electrical tests performed on the device were found to be within specifications.The returned unit did not exhibit any evidence of the reported issue or any defect that may have contributed to the event.It is important to note that devices cannot be functionally tested in a way that fully replicates the anatomical or procedural conditions encountered during the procedure.Device history record review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device analysis findings: a captiflex snare was returned for analysis.Visual examination found no damages to the device.Functional inspection was performed and when the device was connected to the 10-inch loop fixture, the loop could extend properly without any problem.Electrical and continuity testing was performed, and the device was found within specification.In addition, the device was tested with the erbe, and it shows no problem supplying energy to the device.No other damages were noted to the device.Risk review: a risk review was completed and confirmed that the event of device delivers energy intermittently was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of device problem excluded.

• 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: 23623811
• Report Number: 3005099803-2025-06267
• Device Sequence Number: 9031888
• Product Code: FDI
• UDI-Device Identifier: 08714729019459
• UDI-Public: (01)08714729019459(17)280511(10)36497083
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• 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: M00562471
• Device Catalogue Number: 6247
• Device Lot Number: 0036497083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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