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

Model Number	M00562451
Medical Device Problem Codes	Failure to Deliver Energy (1211); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of loop failed to cut.Imdrf device code a090402 captures the reportable event of failure to deliver energy.
Event or Problem Description
It was reported to boston scientific corporation that a captivator device was used in colonoscopy procedure performed on (b)(6) 2024.During the procedure, the nurses reported that physicians were having issues with the 13mm hex device.It was not cutting through polyps effectively or cleanly, and it also failed to cauterize when connected to the cautery unit.The procedure was completed with the same captivator device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
H6: imdrf device code a050702 captures the reportable event of loop failed to cut.Imdrf device code a090402 captures the reportable event of failure to deliver energy.B5 has been updated base on the additional information received on january 30, 2025.
Event or Problem Description
It was reported to boston scientific corporation that a captivator device was used in colonoscopy procedure performed on (b)(6) 2024.During the procedure, the nurses reported that physicians were having issues with the 13mm hex device.It was not cutting through polyps effectively or cleanly, and it also failed to cauterize when connected to the cautery unit.The procedure was completed with the same captivator device.There were no patient complications reported as a result of this event.Additional information received on january 30, 2025: the size of the target polyp was about 8-10 mm and the device was used in the descending colon.In addition, the snare was securely attached to the active cord and there were no visible problems noted with the cautery pin.

• 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 ; CS
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21321624
• Report Number: 3005099803-2025-00396
• Device Sequence Number: 7866020
• Product Code: FDI
• UDI-Device Identifier: 08714729071068
• UDI-Public: 08714729071068
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/18/2025

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: M00562451
• Device Catalogue Number: 6245
• Device Lot Number: 0035188542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 02/18/2025
• Date Device Manufactured: 10/31/2024
• 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