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

Model Number	M00562301
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H: imdrf device code a050702 captures the reportable event of loop failure to cut.H11: the returned captivator snare was analyzed, a visual inspection was performed, and it was found that the working length and wire were kinked at the medium section, and the working length was torn at the tip.Additionally, it was found that the loop was bent.During functional inspection, the device was extended and retracted in the 10- inch loop fixture, and the loop could extend properly without any issue.A continuity and electrical test was performed, and it was noted that the device was found to be within specification.No other problems with the device were noted.The reported event of loop failure to cut was not confirmed.It is likely that these problems occurred due to how the device was handled and manipulated, which may have caused the reported and encountered failures.Excessive manipulation of the device without enough care could have induced the defects found.Therefore, the most probable root cause of this complaint is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used in the colon for the excision of colonic polyp during a cold resection of intestinal polyps procedure performed on (b)(6) 2025.During the procedure, the snare could not extend completely.The snare was unable to cut the target polyp.The procedure was completed with another captivator snare 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.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used in the colon for the excision of colonic polyp during a cold resection of intestinal polyps procedure performed on (b)(6) 2025.During the procedure, the snare could not extend completely.The snare was unable to cut the target polyp.The procedure was completed with another captivator snare 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 h: imdrf device code a050702 captures the reportable event of loop failure to cut.

• 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: 22543424
• Report Number: 3005099803-2025-03269
• Device Sequence Number: 20586496
• Product Code: FDI
• UDI-Device Identifier: 08714729019312
• UDI-Public: (01)08714729019312(17)270812(10)34621942
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: M00562301
• Device Catalogue Number: 6230
• Device Lot Number: 0034621942
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 68 KG