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

Model Number	M00562451
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
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 polypectomy procedure performed on (b)(6) 2025.During the procedure, after cutting a polyp, when the technician was about to cut the second polyp, the metal connector of the electrosurgical generator on the handle suddenly fell off.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 h6: imdrf device code a0501 captures the reportable event of cautery pin detached.
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 polypectomy procedure performed on (b)(6) 2025.During the procedure, after cutting a polyp, when the technician was about to cut the second polyp, the metal connector of the electrosurgical generator on the handle suddenly fell off.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 h6: imdrf device code a0501 captures the reportable event of cautery pin detached.Block h11: the captivator emr device was returned and during visual inspection, it was observed that the working length and wire were kinked at the proximal section (strain relief).Additionally, the device was returned with the cautery pin broken/detached.It is important to mention that the upper part of the cautery pin was not returned for analysis.No other problems with the device were noted.The reported event of cautery pin detached was confirmed.Investigation found that the working length and the wire were kinked at the proximal section (strain relief).Additionally, the cautery pin was detached.These problems likely have occurred due the manner as the device was handled and manipulated may have caused the reported and encountered problems.Excessive manipulation of the device without enough care could have induced the defects found.Also, this issue could have occurred due to the way the active cord was connected or disconnected from the cautery pin (2-in-1 connector), which may have caused the cautery pin to become broken/detached, however, since the upper part of the cautery pin was not retuned for analysis, it is not possible to determine the definitive cause for this issue.Therefore, the most probable root cause is cause not established.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23246236
• Report Number: 3005099803-2025-05225
• Device Sequence Number: 16011660
• Product Code: FDI
• UDI-Device Identifier: 08714729071068
• UDI-Public: (01)08714729071068(17)270816(10)34656028
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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: M00562451
• Device Catalogue Number: 6245
• Device Lot Number: 0034656028
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• 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