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

Model Number	M00562321
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.
Event or Problem Description
Note: this report pertains to one of two captivator snare used in the same procedure.It was reported to boston scientific corporation that a captivator snare was used during an unknown procedure performed on (b)(6) 2025.During the procedure, the physician noticed that there was no current during cautery resection.The procedure was completed with a non-boston scientific device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Event or Problem Description
Note: this report pertains to one of two captivator snare used in the same procedure.It was reported to boston scientific corporation that a captivator snare was used during an unknown procedure performed on (b)(6) 2025.During the procedure, the physician noticed that there was no current during cautery resection.The procedure was completed with a non-boston scientific device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block e1 (initial reporter email) has been updated with the additional information received on october 23, 2025.Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.

• 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: 22344868
• Report Number: 3005099803-2025-02978
• Device Sequence Number: 4825792
• Product Code: FDI
• UDI-Device Identifier: 08714729019336
• UDI-Public: (01)08714729019336(17)270510(10)34008318
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: M00562321
• Device Catalogue Number: 6232
• Device Lot Number: 0034008318
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 11/03/2025
• Date Device Manufactured: 05/10/2024
• 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