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

Model Number	M00561241
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2026.During the procedure, the physician tried to cut the polyp with cautery, but the snare failed to cut and instead the loop became embedded in the target polyp.The sheath and handle of the snare were cut, and the snare was withdrawn from the scope.A new snare was used to cut the polyp and to remove the original snare from the patients tissue.Additionality, the procedure was prolonged, but the polyp site did not require a closure device.Upon examination after the procedure, the prong on the original snare was found to be stable.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a050702 captures the reportable event of device failure to cut.Imdrf device code a150208 captures the reportable event of entrapment of device.Imdrf device code a0401 captures the reportable event of loop break.Imdrf impact code f2301 captures the event of additional device required.Imdrf impact code f23 captures the event of unexpected medical intervention.Block h11 device evaluation: the device returned.During visual analysis it was determined that the device did not have any visual issues/damages.The funcional inspection showed the 10-inch loop could extend and retract properly.Also, a continuity and electrical test were performed, and the device was found within specification.Besides that, the loop was measured and the dimensions were within of specifications.The unit returned did not show evidence of the alleged issues or any defect that could have contributed to the events reported.Therefore, the reported issues were classified as no problem detected.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.The reported prolonged episode of care, unexpected medical intervention and additional device required were classified as adverse event related to the procedure since the adverse events occurred due to the issues encountered during procedure.Based on all gathered information, the probable cause selected is no problem detected.

• 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: 25392687
• Report Number: 3005099803-2026-02306
• Device Sequence Number: 16128981
• Product Code: FDI
• UDI-Device Identifier: 08714729855927
• UDI-Public: (01)08714729855927(17)281120(10)38022165
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00561241
• Device Catalogue Number: M00561241
• Device Lot Number: 0038022165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown