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

Model Number	M00562341
Medical Device Problem Codes	Failure to Deliver Energy (1211); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Imdrf device code a2150208 captures the reportable event of snare loop entrapment.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used to remove polyp during a polypectomy procedure performed on (b)(6) 2025.During the procedure, after injecting the pedicle with a solution of adrenaline and methylene blue, it was looped with a 27 mm hexagonal snare.Despite repeated attempts, no current passed through.Efforts to release the snare were unsuccessful, as it became stuck to part of the polyp.They were only able to mobilize it using tweezers via an endoscope positioned alongside the colonoscope.The procedure was completed with another captivator snare.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 h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Imdrf device code a2150208 captures the reportable event of snare loop entrapment.Block b5 has been updated based on the additional information received on july 9, 2025.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used to remove polyp during a polypectomy procedure performed on (b)(6) 2025.During the procedure, after injecting the pedicle with a solution of adrenaline and methylene blue, it was looped with a 27 mm hexagonal snare.Despite repeated attempts, no current passed through.Efforts to release the snare were unsuccessful, as it became stuck to part of the polyp.They were only able to mobilize it using tweezers via an endoscope positioned alongside the colonoscope.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.Additional information was received on july 9, 2025.The snare was used in the sigmoid colon to remove a 5 cm pedicled, wide base and long polyp.The snare was securely attached to the active cord and no problems were noted with the cautery pin.
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Imdrf device code a2150208 captures the reportable event of snare loop entrapment.Block e1 (initial reporter email) has been updated based on the additional information received on august 7, 2025.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used to remove polyp during a polypectomy procedure performed on (b)(6) 2025.During the procedure, after injecting the pedicle with a solution of adrenaline and methylene blue, it was looped with a 27 mm hexagonal snare.Despite repeated attempts, no current passed through.Efforts to release the snare were unsuccessful, as it became stuck to part of the polyp.They were only able to mobilize it using tweezers via an endoscope positioned alongside the colonoscope.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.Additional information was received on july 9, 2025 the snare was used in the sigmoid colon to remove a 5 cm pedicled, wide base and long polyp.The snare was securely attached to the active cord and no problems were noted with the cautery pin.

• 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: 22350625
• Report Number: 3005099803-2025-02841
• Device Sequence Number: 20040135
• Product Code: FDI
• UDI-Device Identifier: 08714729019350
• UDI-Public: (01)08714729019350(17)271212(10)35477144
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2025

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: M00562341
• Device Catalogue Number: 6234
• Device Lot Number: 0035477144
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 07/09/2025; 08/07/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/04/2025; 08/21/2025
• Date Device Manufactured: 12/12/2024
• 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