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	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code (a090402) captures the reportable event of (device failure to deliver energy).Device evaluation: the device was discarded; therefore, a technical analysis could not be performed.A review was completed of the device history records (dhr) for the device.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on the event description and information provided by the customer there is not enough evidence to determine was due to the physicians technique during the procedure or was related to a device malfunction.Additionally, based on the most relevant information for the complaint including product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process, the definitive cause of the reported issue cannot be established due to lack of evidence.Without proper evaluation of the device, it remains unknown the causes that contributed to the event.For this reason, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was intended to be use in the colon during a colonoscopy procedure performed on (b)(6) 2026.During the procedure, the nurse indicated the snare was not able to connect to heat, even after restating the generator device would not connect.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: 25140111
• Report Number: 3005099803-2026-01712
• Device Sequence Number: 15784119
• Product Code: FDI
• UDI-Device Identifier: 08714729855910
• UDI-Public: (01)08714729855910(17)290108(10)38307128
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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: 0038307128
• 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: 04/20/2026
• Initial Report FDA Received Date: 05/11/2026
• Date Device Manufactured: 01/09/2026
• 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