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

Model Number	M00561232
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used in the stomach during a procedure performed on (b)(6) 2025.During the procedure, the snare was inserted through the scope channel and opened completely but would not close around the polyp at all.They had to completely remove the snare.The procedure was completed with a similar captivator snare device.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.Note: this event has been deemed a mdr- reportable event based on investigation results which revealed that the cautery pin was detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf component code g0405209 captures the reportable event of the cautery pin detached.Block e1: initial reporter alternative number: (b)(6).Block h11: a captivator snare was received for analysis.The visual inspection identified that the handle cannula was detached.Also, it was found that the cautery pin was loosened, and in order to analyze this component, it was fully detached manually, and it was found that the cautery pin was bent.The device was analyzed under magnification, and it was found that the handle cannula had the manufacturing crimping mark and the torque mark.Due to the device's condition, the functional test cannot be performed.No other problems with the device were noted.Investigation found that the cautery pin was loosened, and in order to analyze this component, it was fully detached manually, and it was found that the cautery pin was bent.This could happen due to the way the active cord was connected and disconnected from the cautery pin.Additionally, this failure likely occurred due to how the device was handled and manipulated, which may have caused the reported and encountered failure.Excessive manipulation of the device without enough care could have induced the defect found.Additionally, it was found that the handle cannula was detached in the handle.This could happen due to the damage found in the cautery pin, making the cautery pin couldn't hold tight to the handle cannula.It is important to mention that the tip of the handle cannula had the manufacturing crimping mark and the torque mark, confirming that the handle cannula was well assembled when the device left the manufacturing floor.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used in the stomach during a procedure performed on (b)(6) 2025.During the procedure, the snare was inserted through the scope channel and opened completely but would not close around the polyp at all.They had to completely remove the snare.The procedure was completed with a similar captivator snare device.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.Note: this event has been deemed a mdr- reportable event based on investigation results which revealed that the cautery pin was detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf component code g0405209 captures the reportable event of the cautery pin detached.Block e1: initial reporter alternative number: (b)(6).Block h11: a captivator snare was received for analysis.The visual inspection identified that the handle cannula was detached.Also, it was found that the cautery pin was loosened, and in order to analyze this component, it was fully detached manually, and it was found that the cautery pin was bent.The device was analyzed under magnification, and it was found that the handle cannula had the manufacturing crimping mark and the torque mark.Due to the device's condition, the functional test cannot be performed.No other problems with the device were noted.Investigation found that the cautery pin was loosened, and in order to analyze this component, it was fully detached manually, and it was found that the cautery pin was bent.This could happen due to the way the active cord was connected and disconnected from the cautery pin.Additionally, this failure likely occurred due to how the device was handled and manipulated, which may have caused the reported and encountered failure.Excessive manipulation of the device without enough care could have induced the defect found.Additionally, it was found that the handle cannula was detached in the handle.This could happen due to the damage found in the cautery pin, making that the cautery pin couldn't hold tight the handle cannula.It is important to mention that the tip of the handle cannula had the manufacturing crimping mark and the torque mark, confirming that the handle cannula was well assembled when the device left the manufacturing floor based on the information available and the returned device analysis, the most probable root cause for the reported complaint is adverse event related to procedure.

• 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: 22104622
• Report Number: 3005099803-2025-02440
• Device Sequence Number: 12820228
• Product Code: FDI
• UDI-Device Identifier: 08714729861331
• UDI-Public: 08714729861331
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: M00561232
• Device Catalogue Number: 50296
• Device Lot Number: 0035481414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• 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