MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR EMR; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M00561600
Medical Device Problem Codes	Use of Device Problem (1670); Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code (a04) captures the reportable event of (material integrity problem).Block h3: the device was returned for analysis; however, the investigation is still in progress.A supplemental report will be submitted when the investigation is complete or if additional relevant information becomes available.
Event or Problem Description
It was reported to boston scientific corporation that a captivator emr snare was used in the stomach during a polypectomy procedure performed on (b)(6), 2026.During the procedure, after fixing the snare to the endoscope, the handle conector broke and caused the wire exposure.As a result, the alignment when advancing the snare was difficult.The procedure was completed with the original device.There were no patient complications reported as a result of this event.Note: the complainant reported that the broken device was used to complete the procedure.However, according to the directions for use (dfu), the use of the captivator emr snare is not adequate if the package or component is damaged or opened.It is not intended for use if any damage is found.

• Brand Name: CAPTIVATOR EMR
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• 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: 25140042
• Report Number: 3005099803-2026-01711
• Device Sequence Number: 15831842
• Product Code: FDI
• UDI-Device Identifier: 08714729842675
• UDI-Public: (01)08714729842675(17)260917(10)38179111
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K140726
• 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): 07/07/2026

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 Expiration Date: 09/17/2026
• Device Model Number: M00561600
• Device Catalogue Number: M00561600
• Device Lot Number: 0038179111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2025
• 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