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

Model Number	6122
Medical Device Problem Codes	Failure to Cut (2587); Difficult to Open or Close (2921); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf patient code e2114 captures the reportable event of perforation.Imdrf device code a050702 captures the reportable event of snare loop unable to cut.Imdrf impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used in the transverse colon near the splenic flexure of the large intestine to remove an approximately 5mm benign colorectal polyp during a polypectomy procedure performed on (b)(6) 2025.During the procedure, the device was inserted without resistance, and the snare wire was deployed to capture the polyp.However, mechanical resection was unsuccessful, and during manipulation particularly while strangulating and squeezing the polyp; a pinching sensation was noted, deviating from the expected smooth operation.The scope was then used to attempt resection, which resulted in sheath deformation and a small perforation at the ulcer base, exposing the serous membrane after removal of the muscular layer.The deformation, described as accordion-like bending of the snare working length, was only observed post-procedure and attributed to force applied when the lesion could not be removed.The procedure was completed with the original device.A perforation occurred in the colon wall during the procedure but was successfully treated using clip closure, confirmed via visual inspection with an endoscope.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was used in the transverse colon near the splenic flexure of the large intestine to remove an approximately 5mm benign colorectal polyp during a polypectomy procedure performed on (b)(6) 2025.During the procedure, the device was inserted without resistance, and the snare wire was deployed to capture the polyp.However, mechanical resection was unsuccessful, and during manipulation particularly while strangulating and squeezing the polyp; a pinching sensation was noted, deviating from the expected smooth operation.The scope was then used to attempt resection, which resulted in sheath deformation and a small perforation at the ulcer base, exposing the serous membrane after removal of the muscular layer.The deformation, described as accordion-like bending of the snare working length, was only observed post-procedure and attributed to force applied when the lesion could not be removed.The procedure was completed with the original device.A perforation occurred in the colon wall during the procedure but was successfully treated using clip closure, confirmed via visual inspection with an endoscope.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf patient code e2114 captures the reportable event of perforation.Imdrf device code a050702 captures the reportable event of snare loop unable to cut.Imdrf impact code f2301 captures the reportable event of additional device required.The returned captivator ii was analyzed, and a visual and microscopic evaluation noted that the working length was buckled accordion.In addition, it was found that the working length and wire were kinked at the proximal section.A dimensional test was performed and found out that the dimensions of the tip of sheath to back of cannula and tip of sheath from front of loop were out of specification.In addition, mtac testing was done and found out that the ptfe sheath flopped by mechanical cold deformation, axial compression combined with torsion producing plastic flow and striations.Moreover, a continuity and electrical test was performed, and the device was found within specification.No other problems with the device were noted.The reported event of snare unable to cut was not confirmed.It was found out that the working length was buckled accordion.It was noted that device was found within specification.Based on all gathered information, the most probable root cause assigned is adverse event related to procedure.

• 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: 23038071
• Report Number: 3005099803-2025-04577
• Device Sequence Number: 10054006
• Product Code: FDI
• UDI-Device Identifier: 08714729855903
• UDI-Public: (01)08714729855903(17)280617(10)36786187
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: 6122
• Device Catalogue Number: 6122
• Device Lot Number: 0036786187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• 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: Male