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

Model Number	6123
Medical Device Problem Codes	Failure to Cut (2587); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
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 captivator ii snare was used in the intestine to remove a polyp during a polypectomy procedure performed on (b)(6) 2025.During procedure, the handle was not smooth and there was a problem with the deployment.The snare could be extended with forces applied, but not smooth and could not remove the polyp accurately.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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 captivator ii was analyzed, a visual evaluation noted that the working length was bent at proximal section (strain relief), due to this condition the handle cannula was hitting the sheath inside of the strain relief, leaving scratching marks in the material, making the device difficult to actuate.Functional inspection was done, and the device was extended and retracted in the 10- inch loop fixture and the loop could extend.A second functional test was performed, and the device was actuated manually, and it was difficult to actuate.Lastly, electrical test was conducted, and the device was found within specification.No other problems with the device were noted.The reported event of loop unable to cut was not confirmed.The device had the continuity and electrical test performed in which the device found within specification.The investigation findings and all information available do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, the most probable root cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used in the intestine to remove a polyp during a polypectomy procedure performed on (b)(6) 2025.During procedure, the handle was not smooth and there was a problem with the deployment.The snare could be extended with forces applied, but not smooth and could not remove the polyp accurately.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 22806059
• Report Number: 3005099803-2025-03964
• Device Sequence Number: 7656733
• Product Code: FDI
• UDI-Device Identifier: 08714729855910
• UDI-Public: (01)08714729855910(17)270604(10)34169519
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/27/2025

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: 6123
• Device Catalogue Number: 6123
• Device Lot Number: 0034169519
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 49 KG