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

Model Number	6234
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a090402, captures the reportable event of snare unable to deliver energy.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used during the procedure performed on (b)(6) 2025.During the procedure, after the device was connected to cautery, the settings were adjusted to an unknown configuration.The machine did not deliver energy to the snare.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• Brand Name: CAPTIVATOR
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23767975
• Report Number: 3005099803-2025-06638
• Device Sequence Number: 10615844
• Product Code: FDI
• UDI-Device Identifier: 08714729019350
• UDI-Public: (01)08714729019350
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K202478
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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: 6234
• Device Catalogue Number: 6234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/10/2025
• 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