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

Model Number	M00562301
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used to remove intestinal polyps during a polypectomy procedure performed on (b)(6) 2025.During the procedure, the snare could not be energized and could not be used.The procedure was completed with another of the same 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: this event was reported by the bsc sales representative.The healthcare facility is: (b)(6) hospital.Address: (b)(6).Phone: (b)(6).Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Block h11: (additional information).Blocks b5, e1 (initial reporter title, initial reporter first name, initial reporter last name, initial reporter facility name, initial reporter address 1, initial reporter address 2, initial reporter city, and initial reporter phone), e2 (health professional?), e3 (occupation) have been updated based on the additional information received on may 23, 2025.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used to remove intestinal polyps during a polypectomy procedure performed on (b)(6) 2025.During the procedure, the snare could not be energized and could not be used.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Additional information was received on may 23, 2025.The snare was used in the descending colon to remove a 13 mm flat polyp during an endoscopic mucosal resection (emr) procedure.The snare was securely attached to active cord and there were no problems noted with the cautery pin.No attempts were made to cold cut the polyp.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21938186
• Report Number: 3005099803-2025-01890
• Device Sequence Number: 7884365
• Product Code: FDI
• UDI-Device Identifier: 08714729019312
• UDI-Public: (01)08714729019312(17)260618(10)31848912
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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 Expiration Date: 06/18/2026
• Device Model Number: M00562301
• Device Catalogue Number: 6230
• Device Lot Number: 0031848912
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/17/2025
• Date Device Manufactured: 06/19/2023
• 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: 47 YR
• Patient Sex: Female