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

Model Number	M00562301
Medical Device Problem Codes	Retraction Problem (1536); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator was used during a polypectomy procedure to treat polyps performed on an it was reported that during the procedure, the technician opened the snare, wrapped it around the polyp and then tried to close the snare but the snare would not close.The procedure was completed with another captivator.There were no patient complications reported as a result of this event.Note: this event has been deemed a mdr- reportable event based on investigation results which revealed that the cautery pin was detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf evaluation code c070603 captures the reportable event of cautery pin detach.Block h11: investigation result the returned captivator was analyzed, and it was observed during visual inspection that the cannula was detached.In addition, the cautery pin was also loosened.The device was analyzed under magnification, and it was found out that the cannula had the manufacturing crimping had the manufacturing crimping and torque marks.No other problems with the device were noted.The reported event of loop retraction was confirmed.This problem could be related to the manner on how the device was handled and manipulated.Excessive manipulation of the device without enough care could have induced the defects found.Also, these issues 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 loose.As result, the handle cannula detached.Based on all gathered information, the probable cause selected is adverse event related to procedure.
Event or Problem Description
It was reported that during the procedure, when the tech that was in the procedure opened the snare, and wrapped it around the polyp and then tried to close the snare, the snare would not close.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h2 (correction): block d4 (model number) has been updated based on the correction of model number.Block h6: imdrf evaluation code c070603 captures the reportable event of cautery pin detach.Block h11: investigation result: the returned captivator device was analyzed.The returned device underwent a visual inspection, which revealed that the handle cannula was detached.It was also noted that the cautery pin was loose; this component was manually removed for further evaluation, and no damage was observed.Magnified inspection showed that the handle cannula displayed the original manufacturing crimping and torque marks.Due to the condition of the device, functional testing could not be performed.No other problems with the device were noted.The reported event of loop retraction was confirmed.It was found that the handle cannula was detached and the cautery pin was loose.These issues were likely caused by the way the device was handled and manipulated, which may have contributed to both the reported and observed failures.Excessive or improper manipulation could have induced the defects identified.Additionally, the manner in which the active cord was connected or disconnected from the cautery pin (2-in-1 connector) may have caused the pin to loosen, ultimately leading to the handle cannula detaching.It is important to note that the handle cannula still exhibited its original manufacturing crimping and torque marks.Based on all available information, the probable root cause assigned is adverse event related to procedure.

• 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: 23648447
• Report Number: 3005099803-2025-06351
• Device Sequence Number: 10123362
• Product Code: FDI
• UDI-Device Identifier: 08714729019312
• UDI-Public: (01)08714729019312(17)280615(10)36770274
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: M00562301
• Device Catalogue Number: 6230
• Device Lot Number: 0036770274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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