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

Model Number	M00561291
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	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of loop detached.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2024.During the procedure, the plug from the captivator unexpectedly detached.The procedure was completed with another captivator ii snare.There were no patient complications reported as a result of this event.Note: a photo of the complaint device outside the patient was provided by the customer and shows the cautery pin was detached.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of loop detached.Block h11: the returned captivator ii snare was analyzed, and the device was returned, and upon visual and microscopic inspection, it was found that the cautery pin was broken and detached, as shown in the attached picture.No other device problems were noted.The reported complaint of cautery pin detachment of device or device component was confirmed since the cautery pin was 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).
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2024.During the procedure, the plug from the captivator unexpectedly detached.The procedure was completed with another captivator ii snare.There were no patient complications reported as a result of this event.Note: a photo of the complaint device outside the patient was provided by the customer and shows the cautery pin was detached.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 20427479
• Report Number: 3005099803-2024-05061
• Device Sequence Number: 15360338
• Product Code: FDI
• UDI-Device Identifier: 08714729645801
• UDI-Public: (01)08714729645801(17)270521(10)34077638
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 05/12/2025

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: M00561291
• Device Catalogue Number: 6129
• Device Lot Number: 0034077638
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 05/12/2025
• 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