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

Model Number	M00561241
Medical Device Problem Codes	Failure to Deliver Energy (1211); Mechanical Problem (1384); Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used during endoscopic mucosal resection (emr) of the colon procedure performed on (b)(6) 2025.During the procedure, after tightening the snare around the lesion, energization could not be initiated as expected.During multiple attempts to re-snare, it was discovered that the connection to the active cord had loosened.Eventually, although the output remained weak, energization was successfully achieved, allowing for complete resection of the lesion.However, it was later found that the internal wire within the handle had detached, rendering the snare wire inoperable, it could no longer be opened or closed.The procedure was completed with the original device.There were no patient complications reported as result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of the cautery pin unable to deliver energy.Imdrf device code a0501 captures the reportable event of the cautery pin detached.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used during endoscopic mucosal resection (emr) of the colon procedure performed on (b)(6) 2025.During the procedure, after tightening the snare around the lesion, energization could not be initiated as expected.During multiple attempts to re-snare, it was discovered that the connection to the active cord had loosened.Eventually, although the output remained weak, energization was successfully achieved, allowing for complete resection of the lesion.However, it was later found that the internal wire within the handle had detached, rendering the snare wire inoperable, it could no longer be opened or closed.The procedure was completed with the original device.There were no patient complications reported as result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of the cautery pin unable to deliver energy.Imdrf device code a0501 captures the reportable event of the cautery pin detached.Block h11: investigation result.The returned captivator-snares was analyzed, and a visual evaluation noted that the handle cannula and cautery pin were detached.The cautery pin was not damaged.The device was checked under magnification and found that the handle cannula had the manufacturing crimping and the torque marks.Additionally, due to the condition of the device the functional, continuity and the electrical test could not be performed.No other problems with the device were noted.The reported event of device failure to deliver energy, handle cannula detachment of device or device component, loop failure to extend, loop retraction problem and cautery pin detachment of device or device component were confirmed.It was found that the handle cannula and cautery pin were detached.Also, the device was checked under magnification and found that the handle cannula had the manufacturing crimping and the torque marks.Additionally, due to the condition of the device the functional, continuity and the electrical test could not be performed.These reported failures likely occurred due to the manner in which the device was handled and manipulated.Excessive manipulation of the device could have induced the defects found.Based on all gathered information, the most probable root cause assigned is adverse event related to procedure.

• 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: 23556049
• Report Number: 3005099803-2025-06009
• Device Sequence Number: 9659978
• Product Code: FDI
• UDI-Device Identifier: 08714729855927
• UDI-Public: (01)08714729855927(17)280619(10)36805369
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: M00561241
• Device Catalogue Number: 6124
• Device Lot Number: 0036805369
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• 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