MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT CONTROLLER; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M00542430
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-04859 for the exalt model d scope and for the exalt d controller.It was reported that an exalt d controller was used with an exalt model d single use duodenoscope for an endoscopic retrograde cholangiopancreatography (ercp) procedure on an unknown date.The controller has shown multiple instances where visualization was lost, and the loading screen appeared.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6 (device codes): problem code a06 captures the reportable event of loss of visualization inside the patient.Block h2 (correction): d3 manufacturer address added.Block h11: with all available information, the investigation found the probable cause of the loss of visualization is contamination on the catheter contacts.Although the number of procedures/recycles of the unit are unknown, contamination is likely due to repeat use and wear and tear on the catheter connection, or improper cleaning of the unit during maintenance.Upon receipt, the returned exalt d controller was analyzed.Visual examination of the console identified cosmetic damage on the top cover and front panel.Functional testing of the device identified contamination of the catheter interface contact, causing unstable image.The reported allegation of loss of visualization was confirmed.After replacing the catheter interface contact, the image was clear and stable.With all the available information, boston scientific concludes that the root cause of this event is traced to maintenance, which indicates that problems are traced to improper routine or preventative maintenance.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2024-04859 for the exalt model d scope and 3005099803-2024-04805 for the exalt d controller.It was reported that an exalt d controller was used with an exalt model d single use duodenoscope for an endoscopic retrograde cholangiopancreatography (ercp) procedure on an unknown date.The controller has shown multiple instances where visualization was lost, and the loading screen appeared.No further information has been obtained despite good faith efforts.

• Brand Name: EXALT CONTROLLER
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• 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: 20334692
• Report Number: 3005099803-2024-04805
• Device Sequence Number: 18548778
• Product Code: FDT
• UDI-Device Identifier: 08714729990901
• UDI-Public: 08714729990901
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: 2216800782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown