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

Model Number	M00561311
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a07 captures the reportable event of snare intermittently to deliver energy.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was to be used during an unknown procedure performed on (b)(6) 2025.During the procedure, while scoping the patient and preparing to snare a polyp, the patient was set up for cautery.The grounding pad was placed on the lower left side of the patient's back, and the machine's indicator light was green, signaling readiness.However, as soon as the pedal was pressed to initiate polyp removal, the patient suddenly jumped and reported feeling a shock.The snare was discarded and a new snare from the same lot was used to complete the procedure.There were no patient complications as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.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 (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: 23466849
• Report Number: 3005099803-2025-05660
• Device Sequence Number: 15935611
• Product Code: FDI
• UDI-Device Identifier: 08714729019251
• UDI-Public: (01)08714729019251(17)280217(10)35852026
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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: M00561311
• Device Catalogue Number: 6131
• Device Lot Number: 0035852026
• 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: 10/09/2025
• Initial Report FDA Received Date: 11/04/2025
• Date Device Manufactured: 02/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown