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

Model Number	M00561241
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	03/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator round stiff snare was prepared for use during a procedure performed on (b)(6) 2023.During preparation when the device was tested, it was noted that there was an active cord connector connection problem.Upon inspection, the cautery pin was detached/broken.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Medical device code a0501 captures the reportable event of cautery pin detached.
Event or Problem Description
It was reported to boston scientific corporation that a captivator round stiff snare was prepared for use during a procedure performed on (b)(6) 2023.During preparation when the device was tested, it was noted that there was an active cord connector connection problem.Upon inspection, the cautery pin was detached/broken.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device code a0501 captures the reportable event of cautery pin detached.Block h10 investigation results: a captivator round stiff snare was received for analysis.Visual and microscopic analysis of the returned device revealed that one measure of the 2 in 1 pin was out of specification.During the product analysis, the device was connected with three different cables.The bsi cable had connected well, the device was plugged with non-bsi active cord (conmed and erbe) and the cable also connected; however, no strong force was needed to remove it.Additionally, the 2-1 connector is correctly attached.No other problems were noted.The reported complaint of cautery pin detachment of device or device component could not be confirmed since the 2-1 connector was correctly attached.Based on the information available and the device analysis performed, it was noted that one dimension was not according to the 2 in 1 drawing, therefore, the most probable root cause for the reported complaint is manufacturing deficiency.Capa-00007233 was opened to investigate the issue between the interaction with 2 in 1 connector and the active cord, and issues reported in multiple devices.

• 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; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16680836
• Report Number: 3005099803-2023-01661
• Device Sequence Number: 8116635
• Product Code: FDI
• UDI-Device Identifier: 08714729855927
• UDI-Public: 08714729855927
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133987
• 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): 05/05/2023

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: 08/10/2025
• Device Model Number: M00561241
• Device Catalogue Number: 6124
• Device Lot Number: 0029939295
• 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: 03/17/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• 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