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

Model Number	6247
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Cut (2587); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of snare loop unable to cut.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex snare was used during a colonoscopy procedure performed on (b)(6) 2025.It was reported that during the procedure, the physician was unable to extend the snare from the plastic sheath, which showed signs of imminent breakage due to resistance encountered while actuating the device.In addition, it was also mentioned that there was a cutting issue.The procedure was completed with another captiflex snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2: correction: block e1(initial reporter title).Block h6: imdrf device code a050702 captures the reportable event of snare loop unable to cut.Block h11: investigation result.The returned captiflex, a visual evaluation noted that the working length and wire exhibited kinks at the proximal strain relief and midsection.During functional testing in a 10-inch loop fixture, the device was extended and retracted however, the loop failed to extend properly.Continuity and electrical test were conducted and the device found within specification.No other problems with the device were noted.The reported event of snare unable to cut was not confirmed.It was noted that the working length and wire exhibited kinks at the proximal strain relief and midsection.The reported problem could be related with the manner how the device was handled and manipulated that caused the problem.Excessive manipulation of the device without enough care could have induced the defect found.Therefore, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex snare was used during a colonoscopy procedure performed on (b)(6) 2025.It was reported that during the procedure, the physician was unable to extend the snare from the plastic sheath, which showed signs of imminent breakage due to resistance encountered while actuating the device.In addition, it was also mentioned that there was a cutting issue.The procedure was completed with another captiflex snare.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: 23235567
• Report Number: 3005099803-2025-05083
• Device Sequence Number: 9840580
• Product Code: FDI
• UDI-Device Identifier: 08714729019459
• UDI-Public: (01)08714729019459(17)280118(10)35661315
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: 6247
• Device Catalogue Number: 6247
• Device Lot Number: 0035661315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2025
• 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