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

Model Number	M00562471
Medical Device Problem Codes	Failure to Deliver Energy (1211); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captiflex snare was to be used during colonoscopy procedure performed on (b)(6) 2025.During procedure, there was no cautery energy with the snare.Account assured they have the settings and erby machine set the same way for every procedure.The procedure was completed with another of the same device.There were no patient complications as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Block h11: the returned captiflex was analyzed, and during visual inspection that the working length and wire were kinked.The electrical test was performed, and the device was found within specification and also showed continuity.According to the product analysis performed on the device, it was found that the working length and wire were kinked.These failures likely have occurred due the manner as the device was handled and manipulated may have caused the reported and encountered failures.Excessive manipulation of the device without enough care could have induced the defects found.Based on all available information, the 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 to be used during colonoscopy procedure performed on (b)(6) 2025.During procedure, there was no cautery energy with the snare.Account assured they have the settings and erby machine set the same way for every procedure.The procedure was completed with another of the same device.There were no patient complications as a result of this event.No further information has been obtained despite good faith efforts.

• 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: 23423342
• Report Number: 3005099803-2025-05612
• Device Sequence Number: 8198096
• Product Code: FDI
• UDI-Device Identifier: 08714729019459
• UDI-Public: (01)08714729019459(17)280706(10)36906973
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: 0036906973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2025
• 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