MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR; Snare, Flexible

Model Number	M00562341
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used in the colon during a colonoscopy procedure performed on unknown date.During the procedure, the physician was unable to successfully cut a polyp.After that, when cauterization was applied the snare loop sparked and was unable to successfully cauterize the polyp site.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 b3: the complainant was unable to provide the event date.Therefore, the event date was estimated based on the bsc aware date.Additional information: the lot number was provided, therefore information populated in block d4 (model number, lot number, catalog number, expiration and unique identifier (udi)) and block h4 (device manufacture date) were updated.Block h6: imdrf device code a050702 captures the reportable event of device failure to cut.Imdrf device code a07 captures the reportable event of device delivers energy intermittently.Device evaluation: the device did not return for analysis; therefore, a technical analysis could not be performed.A review of the device history records (dhr) and was completed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Additionally, based on the most relevant information for the complaint including product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process, the definitive cause of the reported issue cannot be established due to lack of evidence.Without proper evaluation of the device, it remains unknown the causes that contributed to the event.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on all gathered information, the probable cause selected 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 ; +1(914)571-6918
• MDR Report Key: 50093023
• Report Number: 3005099803-2026-03104
• Device Sequence Number: 13262360
• Product Code: FDI
• UDI-Device Identifier: 08714729019350
• UDI-Public: (01)08714729019350(17)290209(10)38540119
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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: M00562341
• Device Catalogue Number: M00562341
• Device Lot Number: 0038540119
• 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: 07/06/2026
• Supplement Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/28/2026
• Date Device Manufactured: 02/10/2026
• 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