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

Model Number	M00542421
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d scope was utilized in an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2026, for the treatment of cholangitis and stricture in the common bile duct.During the procedure, plastic stent placement was being performed.Exalt model d scope visualization was lost and the monitor displayed the loading screen followed by the scope error icon.While troubleshooting, the patient became unstable and coded.Due to the patient's condition and a platelet shortage, the procedure was not able to be completed.
Additional Manufacturer Narrative
Block h6: imdrf code a06 captures the reportable event of loss of visualization.Imdrf code e0602 captures the reportable event of cardiac arrest.Imdrf code f1203 captures the reportable event of life threatening illness or injury.

• Brand Name: EXALT Model D Single-Use Duodenoscope
• 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: 50284728
• Report Number: 3005099803-2026-03357
• Device Sequence Number: 9752972
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: (01)08714729993605(17)280303(10)38752039
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 08/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00542421
• Device Catalogue Number: M00542421
• Device Lot Number: 0038752039
• 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: 07/23/2026
• Initial Report FDA Received Date: 08/17/2026
• Date Device Manufactured: 03/04/2026
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown