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

Model Number	6245
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	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a1: patient identifier: (b)(6).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 snare was used in the rectum during a rectal polypectomy procedure performed on (b)(6) 2025.During the procedure, it was noticed that the captivator snare could not be fully opened and was not able cut the polyp.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a1: patient identifier: (b)(6).Block h6: imdrf device code a050702 captures the reportable event of snare loop unable to cut.Block h11: investigation result: the captivator snare was not returned; however, a photo of the complaint device was provided by the customer.Per media analysis, the photo showed that the loop was twisted and not extended.No other problems with the device were noted from the photo.The reported event of loop failure to extend was confirmed.The reported event of loop failure to cut cannot be confirmed.It is possible that this event occurred it is due to the physician's technique during the procedure, or it may have been related to a device malfunction.Cause not established is selected as the most probable cause for these events.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Based on all gathered information, the probable cause selected is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used in the rectum during a rectal polypectomy procedure performed on (b)(6) 2025.During the procedure, it was noticed that the captivator snare could not be fully opened and was not able cut the polyp.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• 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: 23533098
• Report Number: 3005099803-2025-05922
• Device Sequence Number: 15719618
• Product Code: FDI
• UDI-Device Identifier: 08714729071068
• UDI-Public: (01)08714729071068(17)280428(10)36405288
• 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): 12/11/2025

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: 6245
• Device Catalogue Number: 6245
• Device Lot Number: 0036405288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/11/2025
• Date Device Manufactured: 04/29/2025
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 73 KG