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

Model Number	M00562451
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1 (initial reporter address 2): (b)(6).Imdrf device code a090402 captures the reportable event of energy generating problem.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used in the stomach during a polypectomy procedure performed on (b)(6) 2025.During the procedure, upon closing the snare during polypectomy, physician wanted to carry out hot polypectomy and realized that there was no energy transmitted.Nurses and doctor tried to check the erbe machine and reset the machine, attempted to reconnect the banana plug, none of the actions resolved the problem.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used in the stomach during a polypectomy procedure performed on (b)(6) 2025.During the procedure, upon closing the snare during polypectomy, physician wanted to carry out hot polypectomy and realized that there was no energy transmitted.Nurses and doctor tried to check the erbe machine and reset the machine, attempted to reconnect the banana plug, none of the actions resolved the problem.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1 (initial reporter address 2): (b)(6) medical centre d.Block h6: imdrf device code a090402 captures the reportable event of energy generating problem.Block h11: the returned captivator was analyzed, and visual inspection revealed that the working length and wire were kinked in multiple sections.A continuity and electrical test were performed, and the device was found to be within specification.No other problems with the device were noted.The reported allegation of failure to deliver energy was not confirmed.It is possible that the handling of the device during procedure may have caused or contributed the reported observations.Based on all the information available, this investigation is assigned a conclusion of no problem detected.

• 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: 21680567
• Report Number: 3005099803-2025-01149
• Device Sequence Number: 20775469
• Product Code: FDI
• UDI-Device Identifier: 08714729071068
• UDI-Public: (01)08714729071068(17)261128(10)32950242
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 05/19/2025

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: M00562451
• Device Catalogue Number: 6245
• Device Lot Number: 0032950242
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• 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 Sex: Unknown