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

Model Number	M00562451
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
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 that a captivator snare was used to remove a benign non-pedunculated polyps 5-mm polyp during a colonoscopy procedure performed on (b)(6) 2025.During the procedure, while using a single-use electrocautery snare, it was found that the blade was very dull and unable to remove the polyp.The device was immediately replaced, and the patients polyp was then successfully removed.The procedure was completed.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• Brand Name: CAPTIVATOR
• 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
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23536667
• Report Number: 3005099803-2025-05953
• Device Sequence Number: 10202593
• Product Code: FDI
• UDI-Device Identifier: 08714729071068
• UDI-Public: (01)08714729071068(17)280423(10)36357725
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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: Other
• Device Model Number: M00562451
• Device Catalogue Number: 6245
• Device Lot Number: 0036357725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/12/2025
• Date Device Manufactured: 04/24/2025
• 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 Age: 46 YR
• Patient Sex: Male