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

Model Number	M00561231
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of device unable to deliver energy.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare device was used for a polyp in the colon during a colorectal polyp resection procedure performed on (b)(6) 2025.During the procedure, the device was unable to deliver energy.The procedure was completed with another captivator snare device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of device unable to deliver energy.Block h11: investigation results the returned captivator ii snare was analyzed, and a visual evaluation noted no visible damages.Functional inspection was performed and when the device was connected to the 10-inch loop fixture, the loop could extend properly without any issue.In addition, continuity and electrical test were performed and the device passed, indicating a proper connection.No other problems with the device were noted.The reported event of device unable to deliver energy was not confirmed.Upon analysis, it was determined that the device exhibited no visual issues or damage.The device was subjected to a functional test, and the loop was able to extend properly without any issues.Additionally, the continuity and electrical tests performed on the device were found to be within specifications.The returned unit did not show evidence of the alleged issue or any defect that could have contributed to the reported event.Since the device cannot be functionally tested in a manner that fully emulates the anatomical or procedural conditions encountered during the procedure, the most probable root cause of this complaint is device problem excluded.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare device was used for a polyp in the colon during a colorectal polyp resection procedure performed on (b)(6) 2025.During the procedure, the device was unable to deliver energy.The procedure was completed with another captivator snare device.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIVATOR II
• 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: 24004900
• Report Number: 3005099803-2026-00120
• Device Sequence Number: 9215529
• Product Code: FDI
• UDI-Device Identifier: 08714729855910
• UDI-Public: (01)08714729855910(17)280812(10)37191636
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: M00561231
• Device Catalogue Number: 6123
• Device Lot Number: 0037191636
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• 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