MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR? COLD; SNARE, NON-ELECTRICAL

Model Number	M00561100
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complaint was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6 (device codes): imdrf device code a050702 captures the reportable event of device failure to cut.Block h11: investigation results: the complaint device was not returned; therefore, product analysis could not be performed, for this reason and due to the lack of evidence is unable to confirm the reported event.There is not enough evidence to determine whether the issue was induced due to the technique of the physician during the procedure or were related to a device malfunction.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported to boston scientific that a captivator cold snare was used in the colon for a polypectomy removal procedure, performed on an unknown date.During the procedure, the snare failed to cut the polyp.The procedure was completed with an alternate device.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIVATOR? COLD
• Common Device Name: SNARE, NON-ELECTRICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24690876
• Report Number: 3005099803-2026-01096
• Device Sequence Number: 13204275
• Product Code: FGX
• UDI-Device Identifier: 08714729971252
• UDI-Public: (01)08714729971252
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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: M00561100
• Device Catalogue Number: M00561100
• 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: 02/26/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown