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

Model Number	M00561600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator emr device was to be used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2023.During the procedure, the snare broke.The procedure was completed with another captivator emr device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of a snare loop broken.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of a snare loop broken.Block h10: investigation results: the returned captivator emr device was analyzed, and a visual evaluation noted that the handle cannula was kinked, and the working length (strain relief) was smashed at the proximal side.There were no visual problems found in the loop.Microscopic examination was performed which confirmed that the handle cannula was kinked, and the working length (strain relief) was smashed.No other problems with the device were noted.The reported event of snare break was not confirmed as the loop was returned in a good condition.Investigation found that the working length (strain relief) was smashed in the proximal side, leading to the bend found on the cannula and which make impossible to extend the loop.Taking all available information into consideration, the most probable root cause of this event is manufacturing deficiency, as the reported event was traced to the manufacturing process.An investigation to address this problem is in progress.Block h11: correction: block b5 (describe event or problem).
Event or Problem Description
It was reported to boston scientific corporation that a captivator emr device was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2023.During the procedure, it was noticed that the snare was broken when pulled out from the scope.The procedure was completed with another captivator emr device.There were no patient complications reported as a result of this event.

• 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; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17116507
• Report Number: 3005099803-2023-03115
• Device Sequence Number: 17790560
• Product Code: FDI
• UDI-Device Identifier: 08714729842675
• UDI-Public: 08714729842675
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/14/2023

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 Expiration Date: 10/27/2023
• Device Model Number: M00561600
• Device Catalogue Number: 50662
• Device Lot Number: 0030727972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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