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

Model Number	M00561221
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384); Retraction Problem (1536); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation finding of cautery pin detachment of device or device component.Block h11: investigation results the device returned; a technical analysis could be performed.During visual inspection it was found that the handle cannula and cautery pin were detached.The cautery pin was not damaged.Also, under magnification it was found that the handle cannula had the manufacturing crimping and torque marks.Additionally, it was revealed that the wire and loop were not broken.The functional test could not be performed due device condition.A review of the device history record (dhr) was performed.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 product analysis performed on the device the failures likely have occurred as the device was handled and manipulated, excessive manipulation of the device without enough care could have induced the defects found.Also, these issues could have occurred due to the way the active cord was connected or disconnected from the cautery pin (2-in-1 connector), which may have caused the cautery pin to become detached, as result, the handle cannula become detached as well.It is important to mention that the handle cannula had the manufacturing crimping and torque marks.Therefore, these issues were classified as adverse event related to procedure.The reported codes of loop failure to extend and loop retraction problem were classified as adverse event related to procedure since the handle cannula was detached the loop could not be extended or retracted.Also, regarding the reported code loop difficult to position, it was not possible to actuate the device or performed a functionally tested by emulating the anatomical/procedural factors encountered during the procedure, this reported issue was classified as cause not established.Boston scientific has assigned an investigation conclusion code of adverse event related to procedure.
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 snare wire got broken in the middle of the procedure.Additionally, the loop was unable to open or close properly around polyp and caused difficulty to position when tightening.The procedure was complete with an alternative device.There were no patient complications reported as a result of this event.Note: this complaint has been deemed mdr reportable event based on the investigation result which revealed that the pin was detached.Please see h11 for the full investigation details.

• 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: 25513163
• Report Number: 3005099803-2026-02462
• Device Sequence Number: 18798412
• Product Code: FDI
• UDI-Device Identifier: 08714729855903
• UDI-Public: (01)08714729855903(17)290210(10)38581310
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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: M00561221
• Device Catalogue Number: M00561221
• Device Lot Number: 0038581310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2026
• 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