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

Model Number	42421
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d scope was used during an ercp (endoscopic retrograde cholangiopancreatography) procedure performed on (b)(6) 2025.During the procedure, the patient was noted to have a challenging anatomy due to a pancreatic mass.Mucosal trauma and bleeding were noted upon advancing the scope.The physician discontinued the procedure and sent the patient to interventional radiology where it was confirmed there was no perforation.There was no intervention needed for the mucosal trauma or bleed.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of cancelled rescheduled, post sedation, sedation unknown.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of cancelled rescheduled, post sedation, sedation unknown.Block h6: imdrf impact code f2203 removed.Block b5: event description updated.
Event or Problem Description
It was reported to boston scientific corporation that an exalt model d scope was used during an ercp (endoscopic retrograde cholangiopancreatography) procedure performed on (b)(6) 2025.During the procedure, the patient was noted to have a challenging anatomy due to a pancreatic mass.The physician reported mucosal trauma and bleeding caused by the scope.The physician discontinued the procedure.There was no perforation.There was no intervention needed for the mucosal trauma or bleed.

• 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 ; 9145716918
• MDR Report Key: 24014462
• Report Number: 3005099803-2026-00128
• Device Sequence Number: 21116319
• Product Code: FDT
• UDI-Device Identifier: 08714729993605
• UDI-Public: (01)08714729993605(17)270812(10)37191226
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/09/2026

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: 42421
• Device Catalogue Number: 42421
• Device Lot Number: 0037191226
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/09/2026
• Date Device Manufactured: 08/12/2025
• 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 Age: 84 YR
• Patient Sex: Male
• Patient Weight: 56 KG