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

Model Number	6123
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii-15 mm round stiff snare was used in the colon during a polypectomy procedure for colorectal polyps performed on (b)(6) 2024.During the procedure, it was reported that the metal fittings on the active cord and the gold metal fittings had come off.The procedure was completed with another captivator ii-15 mm round stiff snare device.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.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii-15mm round stiff snare was used in the colon during a polypectomy procedure for colorectal polyps performed on (b)(6) 2024.During the procedure, it was reported that the metal fittings on the active cord and the gold metal fittings had come off.The procedure was completed with another captivator ii-15mm round stiff snare device.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 h11: (product investigation) the returned captivator snare was analyzed, and visual and microscope inspection that the 2-in-1 connector was broken and detached.No other device problems were noted.The reported complaint of cautery pin detachment of device or device component was confirmed since the 2-1 pin was broken and detached.Based on the information available and the device analysis performed, the most probable root cause for the reported complaint is manufacturing deficiency.Boston scientific has initiated an investigation to further evaluate cautery pin detachment events to determine root cause of these events, as well as appropriate mitigation(s).

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20871322
• Report Number: 3005099803-2024-06209
• Device Sequence Number: 18286194
• Product Code: FDI
• UDI-Device Identifier: 08714729855910
• UDI-Public: 08714729855910
• 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): 02/17/2025

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: 6123
• Device Catalogue Number: 6123
• Device Lot Number: 0034070521
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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