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); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Fistula (1862); Perforation (2001)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: patient code e2114 captures the reportable event of perforation of the tissue in the stomach.
Event or Problem Description
It was reported to boston scientific corporation that a captivator emr device was used for lesions in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.During the procedure, when the physician sucked in the tissue using the banding device, it acquired too much tissue.Upon resection, the physician accidentally perforated the tissue in the stomach.The procedure was completed with a mantis clip device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspected device lot number.Therefore, the manufacture date and expiration date are unknown.Block h2 (correction): block b5 (describe event or problem), block h6 (impact and device code) has been corrected.Block h6: patient code e2114 captures the reportable event of perforation of the tissue in the stomach.
Event or Problem Description
It was reported to boston scientific corporation that a captivator emr device was used for lesions in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.During the procedure, when the physician sucked in the tissue using the banding device, it acquired too much tissue.Upon resection, the physician accidentally perforated the tissue in the stomach.The procedure was completed with a mantis clip device.There were no patient complications reported as a result of this event.Note: the complainant reported that the physician sucked in too much tissue during banding.Upon resection, he accidently perforated the tissue in the stomach.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspected device lot number.Therefore, the manufacture date and expiration date are unknown.Block h6: patient code e2114 captures the reportable event of perforation of the tissue in the stomach.Block h11: the device was not returned for analysis; therefore, a product analysis could not be performed.For this reason and due to the lack of evidence, it is unable to confirm the reported event.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.A labeling review was performed.The instructions for use (ifu) contains detailed device information and instructions for device use.Additionally, it was confirmed that the following adverse event is anticipated in the ifu: perforation.Also, there is no evidence the device was improperly used per the instructions for use (ifu), and there is no evidence that there is any issue with translation, wording, or graphics of the instructions for use (ifu) or labeling information.A risk review was completed and confirmed that the event of device use of device issue user error (acquired too much tissue) 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.Based on the most relevant information for the complaint, including product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections; no abnormalities were reported during the assembly process.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event.Block h11: correction: block b1 (adverse event/product problem) has been corrected.
Event or Problem Description
It was reported to boston scientific corporation that a captivator emr device was used for lesions in the stomach during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.During the procedure, when the physician sucked in the tissue using the banding device, it acquired too much tissue.Upon resection, the physician accidentally perforated the tissue in the stomach.The procedure was completed with a mantis clip device.There were no patient complications reported as a result of this event.

• 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; propark, coyol; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23934898
• Report Number: 3005099803-2025-06964
• Device Sequence Number: 14855316
• Product Code: FDI
• UDI-Device Identifier: 08714729842675
• UDI-Public: (01)08714729842675
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2026

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: M00561600
• Device Catalogue Number: M00561600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 01/15/2026; 04/10/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 02/09/2026; 04/30/2026
• 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