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

Model Number	M00561223
Medical Device Problem Codes	Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This product was returned to the manufacturer without any report of performance issues or adverse patient effects.The returned device was analyzed, and a foreign material was found inside the unopened pouch.See block h11 for full investigation details.
Additional Manufacturer Narrative
Section e: this event was reported by the sales representative.The health care facility is: (b)(6).(b)(6).Phone: (b)(6).Block h6: imdrf device code a1801 captures the reportable investigation result of foreign material present inside the pouch.Block h11: investigation results.The device was returned for analysis in its unopened pouch.During visual and microscopic inspection, a foreign material was found.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.Product analysis was performed, and it was found that the device had evidence of foreign material inside the original pouch.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.

• 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: 25021199
• Report Number: 3005099803-2026-01552
• Device Sequence Number: 9632281
• Product Code: FDI
• UDI-Device Identifier: 08714729861317
• UDI-Public: (01)08714729861317(17)281209(10)38160096
• 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
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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: M00561223
• Device Catalogue Number: 50297
• Device Lot Number: 0038160096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 04/28/2026
• Date Device Manufactured: 12/10/2025
• 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