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 Code	Perforation (2001)
Date of Event	11/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a captivator emr device was used in the stomach during a gastric endoscopic mucosal resection (emr) procedure performed on (b)(6) 2021.During the procedure, the patient was treated for 8mm neuroendocrine tumor (net) in the greater curve at the proximal stomach.However, following the endoscopic mucosal resection (emr) procedure, a gastric perforation was observed.A non-bsc clip was used to close the gastric perforation and the patient had an overnight hospital stay.There was no reported malfunction of the captivator emr device.The patient made a complete recovery with no surgical intervention needed and has been discharged home.

• 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: 13025624
• Report Number: 3005099803-2021-07812
• Device Sequence Number: 16617840
• Product Code: FDI
• UDI-Device Identifier: 08714729842675
• UDI-Public: 08714729842675
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 12/17/2021

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 Expiration Date: 05/18/2022
• Device Model Number: M00561600
• Device Catalogue Number: 50662
• Device Lot Number: 0027540750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown