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

Model Number	M00561221
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of foreign matter in the packaging.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare device was used in an unknown procedure performed on (b)(6) 2025.During preparation, it was observed that there was a dust-like unknown substance inside the device.The procedure was completed with another captivator snare device.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 snare device was used in an unknown procedure performed on (b)(6) 2025.During preparation, it was observed that there was a dust inside the device.The procedure was completed with another captivator snare device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of foreign matter in the packaging.Block h11: the returned captivator snares was analyzed.The device was returned in its unopened pouch, and a visual evaluation and microscopic inspection were performed, and a foreign material was found inside the pouch.No other problems with the device were noted.It was confirmed this device met manufacturing specifications prior to distribution, and there were no manufacturing deviations which could have contributed to the reported event.The reported event of foreign matter in the packaging was confirmed.Investigation found that the device had evidence of foreign material inside the original pouch.This event was escalated, and it was determined that the cause is related to manufacturing deficiency.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of manufacturing deficiency.An investigation to address this problem is in progress.Block h11: correction: block h7 (if remedial act init, type).

• 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: 23769376
• Report Number: 3005099803-2025-06663
• Device Sequence Number: 9667536
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 6122
• Device Lot Number: 0036786187
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 04/17/2026
• 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
• Patient Sex: Unknown