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

Model Number	M00561291
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of device failure to deliver energy.
Event or Problem Description
Note: this report pertains to the one of three captivator snares that were used in the same procedure.It was reported to boston scientific corporation that a captivator snare was used during a colonoscopy procedure performed on (b)(6) 2024.During the procedure, the physician tried to cauterize with a 33mm captivator snare but was unsuccessful as the snare would not get to the right temperature.A second captivator snare was opened but it did not work.The cautery machine settings, bovie cord and ground pad were checked to ensure proper set up.A third captivator snare was opened, and the same problem occurred.The procedure was completed with a 20mm captivator snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of device failure to deliver energy.Block h11 investigation results: one captivator snare was received for analysis.Visual analysis of the returned device revealed no problems.Additionally, an electrical test was performed, and the device was found within specification.No problems were noted.The reported event of "device failure to deliver energy" could not be confirmed.The device was returned without any problems on it.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.This code was selected since the reported event could not be confirmed.
Event or Problem Description
Note: this report pertains to the one of three captivator snares that were used in the same procedure.It was reported to boston scientific corporation that a captivator snare was used during a colonoscopy procedure performed on (b)(6) 2024.During the procedure, the physician tried to cauterize with a 33mm captivator snare but was unsuccessful as the snare would not get to the right temperature.A second captivator snare was opened but it did not work.The cautery machine settings, bovie cord and ground pad were checked to ensure proper set up.A third captivator snare was opened, and the same problem occurred.The procedure was completed with a 20mm captivator snare.There were no patient complications reported as a result of this event.

• 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: 19982743
• Report Number: 3005099803-2024-03740
• Device Sequence Number: 16828413
• Product Code: FDI
• UDI-Device Identifier: 08714729645801
• UDI-Public: 08714729645801
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: 03/26/2025
• Device Model Number: M00561291
• Device Catalogue Number: 6129
• Device Lot Number: 0029112760
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2022
• 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