MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Captivator EMR; Captivator EMR Snare

Model Number	M00561600
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of detachment of device or device component.Device evaluation.The device was not returned for analysis; therefore, a technical analysis could not be 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.A risk review of the captivator emr device was completed and confirmed that the event of suture detachment of device or device component was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A labeling review was performed using windchill.The ifu contains detailed device information and instructions for the device use.There is no evidence the device was improperly used per the ifu, and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.Based on the event description and information provided by the customer there is not enough evidence to determine whether the suture detachment of device or device component was due to the physician's technique during the procedure or was related to a device malfunction.For this reason, cause not established is selected as the most probable cause for this event.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.All compiled information on this investigation determines that the most probable cause is "cause not established".No further escalation its required.
Event or Problem Description
It was reported to boston scientific that a captivator emr was used in the esophagus for a gastroscopy procedure performed on (b)(6) 2026.During the procedure the cap of the captivator emr containing the bands had the release thread attached only from the third band onwards, preventing proper sequential deployment as intended.Procedure was completed with the original device.There were no patient complications as a result of this event.

• Brand Name: Captivator EMR
• Common Device Name: Captivator EMR Snare
• 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 ; +1(914)571-6918
• MDR Report Key: 25123460
• Report Number: 3005099803-2026-01685
• Device Sequence Number: 18301386
• Product Code: FDI
• UDI-Device Identifier: 08714729842675
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K140726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

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: 05/02/2026
• Device Model Number: M00561600
• Device Catalogue Number: M00561600
• Device Lot Number: 0036869337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 08/13/2026
• Date Device Manufactured: 05/02/2025
• 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