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

Model Number M00561600

Device Problem Unsealed Device Packaging (1444)

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

Event Date 12/12/2022

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).

Event Description

Note: this report pertains to one of two captivator emr devices used during the same procedure.It was reported to boston scientific corporation that two captivator emr devices were intended to be used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.During preparation, the sterile packaging of the emr kit were opened and the sterile barrier was compromised.The same problem occurred with the second captivator emr device.The procedure was completed with the third captivator emr device.There were no patient complications reported as a result of this event.

Event Description

Note: this report pertains to one of two captivator emr devices used during the same procedure.It was reported to boston scientific corporation that two captivator emr devices were intended to be used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2022.During preparation, the sterile packaging of the emr kit was opened and the sterile barrier was compromised.The same problem occurred with the second captivator emr device.The procedure was completed with a third captivator emr device.There were no patient complications reported as a result of this event.Additional information received on january 11, 2023: it was reported to boston scientific corporation that the two captivator emr devices were intended to be used in the esophagus.Additionally, it was noticed that the device pouch was torn.

Manufacturer Narrative

Block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.

• 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 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16109151
• MDR Text Key: 308542024
• Report Number: 3005099803-2022-07905
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561600
• Device Catalogue Number: 50662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 02/03/2023
• 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