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

Model Number	M00542430
Medical Device Problem Codes	Connection Problem (2900); Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf 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 3005099803-2025-04313 for the exalt model d scope and report number for the exalt model d controller.It was reported to boston scientific that an exalt model d single use duodenoscope was used with an exalt model d controller was used during an endoscopic retrograde cholangiopancreatography on (b)(6) 2025.During the procedure, the exalt model d scope was intermittently unable to be detected by the controller.Visualization was lost while the scope was in the patient.Additionally, the connection between scope and console felt loose and the clicking sound for scope connection was very faint.The procedure was completed with a reusable scope.No patient complications reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization.Evaluation summary: the returned exalt model d controller was analysis.During the visual inspection, it was observed that the catheter interface contacts have a layer of unknown contamination causing the intermittent video.Therefore, the reported events of controller connection issues and loss of visualization are confirmed.Boston scientific concludes from all compiled information that the most probable cause is cause traced to maintenance.A labeling review was performed.The ifu includes specific warnings/instructions such as: use a 15 to 70 percent isopropyl alcohol in purified water solution and a cloth to clean the controller enclosure, front panel, and power cable do not allow fluids to enter the enclosure, power cable connections, catheter cable receptacle, or component/accessory connections.There is no indication that the device was not used in accordance with the ifu.In addition, during the product analysis, corrosive damage to the housing was found.Since an expected or random component failure was identified without any design or manufacturing issue, the conclusion code of cause traced to component failure is selected.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number: 3005099803-2025-04313 for the exalt model d scope and report number: 3005099803-2025-04177 for the exalt model d controller.It was reported to boston scientific that an exalt model d single use duodenoscope was used with an exalt model d controller was used during an endoscopic retrograde cholangiopancreatography on (b)(6) 2025.During the procedure, the exalt model d scope was intermittently unable to be detected by the controller.Visualization was lost while the scope was in the patient.Additionally, the connection between scope and console felt loose and the clicking sound for scope connection was very faint.The procedure was completed with a reusable scope.No patient complications reported as a result of the event.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22883456
• Report Number: 3005099803-2025-04177
• Device Sequence Number: 18542945
• Product Code: FDT
• UDI-Device Identifier: 08714729990901
• UDI-Public: (01)08714729990901(11)200729(10)2021100040
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/04/2025

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: M00542430
• Device Lot Number: 2021100040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2020
• 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 Sex: Unknown