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

Model Number	M00561231
Medical Device Problem Codes	Failure to Deliver Energy (1211); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of snare loop unable to cut.Imdrf device code a090402 captures the reportable event of snare unable to deliver energy.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used during an endoscopic mucosal resection procedure performed on (b)(6) 2025.During the procedure, puncture and ablation had occurred due to energization failure.Energization was possible halfway through; however, it could no longer be performed during the final polyp resection.The snare was securely attached to the active cord.No visible problem was noted with the cautery pin.The procedure was completed with another captivator ii snare.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of snare loop unable to cut.Imdrf device code a090402 captures the reportable event of snare unable to deliver energy.Block h11: investigation result, the returned captivator snare was analyzed, and a visual evaluation noted that the device was returned without any visible problems.Electrical and continuity testing was performed, and the device was found within specification.Finally, the device was tested with the erbe plugged to it, the erbe shows no problem supplying the energy to the snare.No other problems with the device were noted.The reported event of loop unable to cut and device unable to deliver energy was not confirmed.Upon analysis, the device was returned undamaged and showed no evidence of any defect that could have contributed to the reported event.Additionally, since the device cannot be functionally tested under anatomical or procedural conditions, the most probable root cause of this complaint is classified as "no problem detected.".
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used during an endoscopic mucosal resection procedure performed on (b)(6) 2025.During the procedure, puncture and ablation had occurred due to energization failure.Energization was possible halfway through; however, it could no longer be performed during the final polyp resection.The snare was securely attached to the active cord.No visible problem was noted with the cautery pin.The procedure was completed with another captivator ii snare.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• 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: 23637416
• Report Number: 3005099803-2025-06335
• Device Sequence Number: 9988267
• Product Code: FDI
• UDI-Device Identifier: 08714729855910
• UDI-Public: (01)08714729855910(17)280812(10)37191636
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: 6123
• Device Lot Number: 0037191636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• 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