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

Model Number	M00561291
Medical Device Problem Codes	Failure to Deliver Energy (1211); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used during an unknown procedure performed on an unknown date.During the procedure and inside the patient, the device was unable to deliver energy.No visible problem was noted with the cautery pin.The snare was securely attached to the active cord.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
B3: approximated based on the date the manufacturer became aware of the event.H6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Block h11: investigation results- the returned captivator ii snare was analyzed.A visual inspection revealed that the working length and wire were kinked at the proximal section (strain relief), and the tip of the sheath was damaged or smashed.Electrical and continuity testing were performed, and the device was found to be within specification.Additionally, the device was tested with the erbe system, which confirmed that it shows no problem supplying energy to the snare.No other problems were noted with the device.The reported event of snare unable to deliver energy was not confirmed.Upon analysis, the observed problems likely resulted from the way the device was handled and manipulated.Improper or excessive manipulation without adequate care may have caused the reported and encountered problems.Therefore, the most probable root cause of this complaint is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used during an unknown procedure performed on an unknown date.During the procedure and inside the patient, the device was unable to deliver energy.No visible problem was noted with the cautery pin.The snare was securely attached to the active cord.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.

• Brand Name: CAPTIVATOR II
• 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: 22642819
• Report Number: 3005099803-2025-03491
• Device Sequence Number: 15611469
• Product Code: FDI
• UDI-Device Identifier: 08714729645801
• UDI-Public: (01)08714729645801(17)251013(10)30346002
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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 Expiration Date: 10/13/2025
• Device Model Number: M00561291
• Device Catalogue Number: 6129
• Device Lot Number: 0030346002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• 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