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

Model Number	M00561231
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a090402 captures the reportable event of unable to deliver energy.Block h11: investigation result: the device was not returned for analysis; therefore, product analysis could not be carried out.For this reason and due to the lack of evidence, it is unable to confirm the reported event.It was confirmed this device met manufacturing specifications prior to distribution, and there were no manufacturing deviations which could have contributed to the reported event.Based on the event description and the information provided by the customer, there is insufficient evidence to determine whether the device failure to deliver energy was due to physician technique during the procedure or a device related malfunction.Without a proper evaluation of the device, the most probable causes contributing to the event remain undetermined.Additionally, the product record review did not identify any potential product quality issues or evidence of new patient harm.Based on all available information, the probable root cause assigned is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a captivator - snare was used in the stomach during a polypectomy procedure for the removal of an 8 mm polyp, performed on (b)(6) 2026.During the procedure, when the physician captured the polyp, he pushed the pedal to hot polypectomy, however, nothing happened.The procedure was completed with another of the same device.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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25751095
• Report Number: 3005099803-2026-02728
• Device Sequence Number: 10532044
• Product Code: FDI
• UDI-Device Identifier: 08714729855910
• UDI-Public: (01)08714729855910(17)281215(10)38205897
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 07/08/2026

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: M00561231
• Device Catalogue Number: M00561231
• Device Lot Number: 0038205897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 07/08/2026
• Date Device Manufactured: 12/16/2025
• 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