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

Model Number	M00562471
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); Material Split, Cut or Torn (4008)
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 h6 (device code).Block h6: imdrf device code a050702 captures the reportable event of snare loop unable to cut.Block h11: investigation result the returned captiflex was analyzed, and a visual and microscopic evaluation noted that the flare was detached from the working length (strain relief) and handle.The device was checked under magnification and found that the working length had evidence of the flare being made.In addition, it was also found that the working length and wire were kinked at the proximal section.No other problems with the device were noted.The reported event of bands unable to cut was not confirmed.It was found that the flare was detached from the working length (strain relief) and handle.Also, the device was checked under magnification and noted that the working length had evidence of the flare being made.Additionally, it was found that the working length and wire were kinked at proximal section.These reported failures likely occurred due to manner in which the device was handled and manipulated.Excessive manipulation of the device could have induced the defects found.Based on all gathered information, the most probable root cause assigned 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.
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of snare loop unable to cut.Block h11: investigation result the returned captiflex was analyzed, and a visual and microscopic evaluation noted that the flare was detached from the working length (strain relief) and handle.The device was checked under magnification and found that the working length had evidence of the flare being made.In addition, it was also found that the working length and wire were kinked at the proximal section.Due to the device condition the functional and electrical test could not be performed.Lastly, the working length was not torn.No other problems with the device were noted.The reported event of loop unable to cut was not confirmed.It was found that the flare was detached from the working length (strain relief) and handle.Also, the device was checked under magnification and noted that the working length had evidence of the flare being made.Additionally, it was found that the working length and wire were kinked at proximal section.These reported failures likely occurred due to manner in which the device was handled and manipulated.Excessive manipulation of the device could have induced the defects found.Based on all gathered information, the most probable root cause assigned 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: 23234702
• Report Number: 3005099803-2025-05082
• Device Sequence Number: 8615872
• Product Code: FDI
• UDI-Device Identifier: 08714729019459
• UDI-Public: (01)08714729019459(17)280509(10)36464224
• 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,Followup
• Report Date (Section B): 01/14/2026

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: 0036464224
• 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: 11/13/2025; 12/23/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 12/08/2025; 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2025
• 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