MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXALT? Model D; Duodenoscope And Accessories, Flexible/Rigid

Model Number	M00542420
Medical Device Problem Codes	Fluid/Blood Leak (1250); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a exalt model d was used during an ercp (endoscopic retrograde cholangiopancreatography) procedure performed on (b)(6) 2026 for an unknown treatment.During the procedure, close to the end the visualization was lost.It was reported fluid was noted exiting through the biopsy cap during the case.The procedure was completed with the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization.Block h11: the complaint device was not returned; therefore, product analysis could not be performed.Due to the lack of evidence, the reported event could not be confirmed.Device technical analysis not performed, as the device was not returned for evaluation.A risk review was completed and confirmed that the event of scope loss of visualization was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.It was confirmed this device met manufacturing specifications prior to distribution, and there were no manufacturing deviations that could have contributed to the reported event.The most probable cause of the reported issue could not be established due to insufficient evidence and the inability to evaluate the device.Cause not established.No further escalation is required.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25451110
• Report Number: 3005099803-2026-02394
• Device Sequence Number: 10410045
• Product Code: FDT
• UDI-Device Identifier: 08714729983514
• UDI-Public: (01)08714729983514(17)280121(10)38405250
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K193202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2026

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: M00542420
• Device Catalogue Number: M00542420
• Device Lot Number: 0038405250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2026
• 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