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

Model Number	M00561291
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of the cautery pin detached.
Event or Problem Description
It was reported to boston scientific corporation that a captivator extra large round stiff snare was used during a procedure performed on (b)(6) 2023.During the procedure, the device was unable to be fixed even after the active cord was inserted, so it came off.The procedure was completed with another captivator extra large round stiff snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of the cautery pin detached.Block h10: investigation results.Additional information received on 18 january 2024: block b5 (describe event or problem) and block h6 (device codes).Block h6 has been updated based on additional information received on 18 january 2024.Additionally, a captivator extra large round stiff snare was received for analysis.Visual and microscopic inspection of the returned device revealed no problems.Functional inspection was performed, and device was tested with a boston scientific active cord and the device was connected properly.The device was then plugged with non-boston scientific active cords, and the cables were connected properly.No problems were noted.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.
Event or Problem Description
It was reported to boston scientific corporation that a captivator extra large round stiff snare was used during a procedure performed on (b)(6) 2023.During the procedure, the device was unable to be fixed even after the active cord was inserted, so it came off.The procedure was completed with another captivator extra large round stiff snare.There were no patient complications reported as a result of this event.Additional information received 18 january 2024.It was reported that the cautery pin was not detached, the problem was that the snare was having difficulty connecting with the active cord.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.

• 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 DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18534242
• Report Number: 3005099803-2024-00030
• Device Sequence Number: 17825454
• Product Code: FDI
• UDI-Device Identifier: 08714729645801
• UDI-Public: 08714729645801
• 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): 02/15/2024

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: 12/13/2025
• Device Model Number: M00561291
• Device Catalogue Number: 6129
• Device Lot Number: 0030714591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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