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

Model Number	M00561600
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).
Event or Problem 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 or Problem 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.
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.

• 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: 16109151
• Report Number: 3005099803-2022-07905
• Device Sequence Number: 7673560
• Product Code: FDI
• UDI-Device Identifier: 08714729842675
• UDI-Public: 08714729842675
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 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
• 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): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown