MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT CONTROLLER; ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY

Model Number	M00542430
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code a06 captures the reportable event of loss of visualization.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-01115 for the for the exalt model d single-use duodenoscope.It was reported to boston scientific corporation that an exalt model d controller was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat choledocholithiasis on (b)(6) 2023.During the procedure, while using exalt model d controller, the exalt model d error screen was displayed before the scope insertion into the patient's anatomy.The scope was unplugged and plugged back, and the image was able to be regained.However, the device was reintroduced into the patient's anatomy and the image was lost again.The scope was then removed from the patient, and a reusable scope was used to complete the procedure without patient complications.
Additional Manufacturer Narrative
Block h6: device code a06 captures the reportable event of loss of visualization.Block h10: the returned exalt model d controller was analyzed and it was found that the front panel and top cover have finish damage.The catheter interface contacts were layered with unknown contamination.Product analysis was unable to duplicate the customer complaint.With all gathered information, boston scientific concludes the most probable root cause for this investigation is cause traced to maintenance.The number of procedures and recycles of the unit, handling during use and reprocessing over time are unknown, therefore it is probable that that problems are intermittent and are traced to improper routine or preventative maintenance.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the directions for use (ifu) / product label.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-01115 for the for the exalt model d single-use duodenoscope.It was reported to boston scientific corporation that an exalt model d controller was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat choledocholithiasis on (b)(6) 2023.During the procedure, while using exalt model d controller, the exalt model d error screen was displayed before the scope insertion into the patient's anatomy.The scope was unplugged and plugged back, and the image was able to be regained.However, the device was reintroduced into the patient's anatomy and the image was lost again.The scope was then removed from the patient, and a reusable scope was used to complete the procedure without patient complications.

• Brand Name: EXALT CONTROLLER
• Common Device Name: ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): ENERCON TECHNOLOGIES; 25 northbrook dr; 665; gray ME 04039
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16512067
• Report Number: 3005099803-2023-01264
• Device Sequence Number: 20428589
• Product Code: FET
• UDI-Device Identifier: 08714729990932
• UDI-Public: 08714729990932
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K193202
• 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): 05/12/2023

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: M00542430
• Device Catalogue Number: 4243
• Device Lot Number: 2209700719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 23 YR
• Patient Sex: Unknown