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

Model Number	M00562391
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	11/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf 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 snare was used in the colon during a polypectomy procedure performed on (b)(6) 2024.During the procedure, the electrical cutting connector on the snare handle was detached the electrical cutting function could not be used.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
H6: imdrf device code a0501 captures the reportable event of cautery pin detached.H11: the returned captivator - snare was analyzed, and visual and microscopic inspection found that the 2-in-1 connector was broken and detached.No other device problems were noted.The reported event of the cautery pin detachment of device or device component was confirmed.Upon analysis, the 2-in-1 connector was broken and detached.Based on all available information and the analysis of the returned device, the most probable cause of this 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).
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used in the colon during a polypectomy procedure performed on (b)(6) 2024.During the procedure, the electrical cutting connector on the snare handle was detached, so the electrical cutting function could not be used.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20836408
• Report Number: 3005099803-2024-06073
• Device Sequence Number: 12946301
• Product Code: FDI
• UDI-Device Identifier: 08714729019404
• UDI-Public: 08714729019404
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• 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 Expiration Date: 05/11/2026
• Device Model Number: M00562391
• Device Catalogue Number: 6239
• Device Lot Number: 0031605986
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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 Age: 47 YR
• Patient Sex: Male
• Patient Weight: 65 KG