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

Model Number M00561600

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a captivator endoscopic mucosal resection device was used in the colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2023.During the procedure, the emr device was placed at the end of the scope and was inserted into the patient.A metallic colored residue was visible on the monitor which was removed through suction and irrigation.The emr device was then removed from the patient, and the metallic colored residue was removed with a gauze.It was also noted that a small amount of metallic colored residue was visible in the irrigation solution in the suction canister.The procedure was completed with a cook captivator endoscopic mucosal resection device.It was reported that no immediate harm was caused to the patient.

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.Adverse event problem imdrf device code a180104 captures the reportable event of foreign material present in the device.

• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16655279
• MDR Text Key: 312419235
• Report Number: 3005099803-2023-01674
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729842675
• UDI-Public: 08714729842675
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2023
• Device Model Number: M00561600
• Device Catalogue Number: 50662
• Device Lot Number: 0030677921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• 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