MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX ERCP CANNULA; CATHETER, CHOLANGIOGRAPHY

Model Number	M00545780
Medical Device Problem Codes	Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two devices that were used in the same patient and procedure.It was reported to boston scientific corporation that an rx ercp cannula was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat 22008078 performed on (b)(6) 2026.During the preparation, it was reported that there was plastic (not part of the cannula) inside the lumen of the cannula where the lumen gets narrower.It prohibited a 0.035 or a 0.025 wire from making it through the lumen to the tip of the cannula.The procedure was completed with the original device utilizing a 0.018 guidewire.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material on the device.

• Brand Name: RX ERCP CANNULA
• Common Device Name: CATHETER, CHOLANGIOGRAPHY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24218170
• Report Number: 3005099803-2026-00365
• Device Sequence Number: 9366313
• Product Code: GBZ
• UDI-Device Identifier: 08714729268673
• UDI-Public: (01)08714729268673(17)260502(10)33949269
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K970054
• 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
• Report Date (Section B): 01/29/2026

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 Expiration Date: 05/02/2026
• Device Model Number: M00545780
• Device Catalogue Number: M00545780
• Device Lot Number: 0033949269
• 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: 01/09/2026
• Initial Report FDA Received Date: 01/29/2026
• Date Device Manufactured: 05/02/2024
• 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