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

Model Number M00561610

Device Problems Use of Device Problem (1670); Suction Problem (2170)

Patient Problem Perforation (2001)

Event Date 01/28/2022

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.(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 Description

It was reported to boston scientific corporation that a captivator endoscopic mucosal resection device was used during a endoscopic mucosal resection (emr) procedure performed on (b)(6), 2022.When the device was opened the blue cap was dropped/lost so the blue cap was missing.The technician used their finger to complete suction loop instead.The device was successfully used in the antrum.When used in the fundus, the band captured muscularis due to too much suction and the band was deployed over the whole wall and was not realized until after it was cut, and a perforation occurred.The procedure was successfully completed with a non-bsc clip device.The patient outcome was reported to be fully recovered.There was no additional intervention required and the patient was not admitted to the hospital beyond standard of care.The patient condition at the conclusion of the procedure was reported to be fine.

• Brand Name: CAPTIVATOR EMR
• Type of Device: 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
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13639856
• MDR Text Key: 287425499
• Report Number: 3005099803-2022-00986
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729842699
• UDI-Public: 08714729842699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561610
• Device Catalogue Number: 50661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention