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

Model Number	M0054242CE0
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: device code a090208 is being used to capture the reportable event of scope poor quality image.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2025-02078 for exalt model d scope and 3005099803-2025-02206 for the exalt model d controller.It was reported to boston scientific corporation that an exalt model d scope was used with an exalt model d controller during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the image was blurry and could not be cleared with irrigation.The procedure was completed using the original device, a reusable scope was used for verification.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6.Device code a090208 is being used to capture the reportable event of scope poor quality image.Block h11 the device did not return for product analysis; however, a media analysis was performed.The customer provided photographs where a blurry section in the top left corner of the camera's point of view can be observed.The reported event was confirmed.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.The product was not returned for analysis to identify any defect with the device.Additionally, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2025-02078 for exalt model d scope and 3005099803-2025-02206 for the exalt model d controller.It was reported to boston scientific corporation that an exalt model d scope was used with an exalt model d controller during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the image was blurry and could not be cleared with irrigation.The procedure was completed using the original device, a reusable scope was used for verification.There were no patient complications reported as a result of this event.

• Brand Name: EXALT? MODEL D
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22021330
• Report Number: 3005099803-2025-02078
• Device Sequence Number: 13132516
• Product Code: FDT
• UDI-Device Identifier: 08714729995746
• UDI-Public: (01)08714729995746
• 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): 07/16/2025

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: M0054242CE0
• Device Catalogue Number: M0054242CE0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female