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

Model Number	M00561311
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
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.Imdrf impact code f08 captures the event of hospitalization or prolonged hospitalization.Device evaluation: the device was returned incomplete.During visual and microscopy inspection it was found that the working length and wire had been cut from the device, but the cut section did not return for the analysis.Due to this condition, it was not possible to perform the electrical and dimensional test.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.A labeling review was performed, and it was found the instructions for use (ifu) contains detailed device information and instructions for the device use.Additionally, it was confirmed that the adverse event of perforation is anticipated in the ifu.Also, there is no evidence the device was improperly used per the ifu, and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.It was not possible to perform tests for the reported events of loop failure to cut, loop entrapment of device or device component and loop break.Therefore, these reported issues were classified as cause not established.Also, the reported perforation was classified as known inherent risk of device since the ifu states this condition as a possible adverse event.The visible cut for the wire and working length likely occurred to remove the snare from inside of the patient because the snare could not be extracted from it; therefore, the event was classified as adverse event related to procedure.Finally, the reported events of hospitalization or prolonged hospitalization, unexpected medical intervention and additional device required were classified as adverse event related to procedure since the adverse events occurred due to the issues encountered during procedure.Based on all gathered information, the probable cause selected is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used during a colonoscopy procedure performed on (b)(6) 2026, for a polyp removal.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.The polyp site was closed using clips.Upon examination after the procedure, the prong on the original snare was found to be loose.The event resulted in patient perforation and prolonged hospitalization beyond standard care.No additional patient complications were reported as a result of this event.

• Brand Name: CAPTIVATOR
• 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: 25394962
• Report Number: 3005099803-2026-02308
• Device Sequence Number: 5252061
• Product Code: FDI
• UDI-Device Identifier: 08714729019251
• UDI-Public: (01)08714729019251(17)290119(10)38368593
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• 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: M00561311
• Device Catalogue Number: M00561311
• Device Lot Number: 0038368593
• 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: 01/20/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown