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

Model Number	M00561600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Perforation (2001)
Date of Event	08/01/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to 08/01/2024 based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to report the suspected device lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf patient codes e2330 and e2114 capture the reportable events of patient pain and perforation.Imdrf impact codes f08 and f02 are being used to capture the prolonged hospitalization and the patient's death.
Event or Problem Description
It was reported to boston scientific corporation that a captivator endoscopic mucosal resection device was used in the esophagus during a procedure performed on an unknown date.The procedure was completed successfully; however, when the patient went home, the patient started complaining of pain.The patient ended up going back to the emergency room, where a perforation was found in the esophagus.The patient ended up passing away, but the exact cause of death was not reported.The physician stated that the placement of the band may have been into the muscle layer.No further information has been obtained despite good faith efforts.The physician reported that the incident occurred few years ago and noted that information regarding the event was limited.

• 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20171400
• Report Number: 3005099803-2024-04409
• Device Sequence Number: 7113462
• Product Code: FDI
• UDI-Device Identifier: 08714729842675
• UDI-Public: 08714729842675
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 09/09/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00561600
• Device Catalogue Number: 50662
• 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: 08/16/2024
• Initial Report FDA Received Date: 09/09/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown