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

Model Number	M00561291
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of snare loop detachment of device or device component.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 to be used during endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.It was reported that during the procedure, a previously placed plastic stent (unknown brand) was removed.When attempting to retrieve the stent through the scope using the captivator ii snare device, minimal resistance was encountered.Upon inspection of the captivator ii snare tip, the snare loop was found to be missing and was confirmed to have fallen into the duodenum.The plastic stent and snare loop were successfully retrieved using biopsy forceps, and the procedure continued without further issues.Upon examination of the retrieved snare loop, it was noted that the connection at the base of the loop had detached.The procedure was completed with another of the different device.There were no patient complications as a result of this event.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii snare was to be used during endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During procedure, a previously placed plastic stent was removed.When attempting to retrieve it through the scope using the device, minimal resistance was encountered.Upon inspection of the tip, the snare loop was found to be missing and was confirmed to have fallen into the duodenum.The plastic stent and snare loop were successfully retrieved using biopsy forceps, and the procedure continued without further issues.Upon examination of the retrieved snare loop, it was noted that the connection at the base of the loop had detached.The procedure was completed with another of the different device.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 a0501 captures the reportable event of snare loop detachment of device or device component.Imdrf impact code f2301 captures the reportable event of additional device required.Block h11: the returned captivator ii was analyzed, and a visual and microscope inspection that the loop with the cannula was detached form the wire, these components did not return for analysis.Additionally, during the microscope inspection it was found tip of the wire was blackened, which indicates that the core wire was welded.According to the product analysis performed on the device, it was found that the working length was kinked at distal section (tip of the sheath).This failure likely has occurred due the manner as the device was handled and manipulated may have caused the reported and encountered failure.Excessive manipulation of the device without enough care could have induced the defect found.Based on all available information, the probable root cause assigned is cause traced to intentional off-label, unapproved, or contraindicated use.

• 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: 23426368
• Report Number: 3005099803-2025-05657
• Device Sequence Number: 13168337
• Product Code: FDI
• UDI-Device Identifier: 08714729645801
• UDI-Public: (01)08714729645801(17)280505(10)36441815
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: M00561291
• Device Catalogue Number: 6129
• Device Lot Number: 0036441815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2025
• 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