MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX¿ BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00534350
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: patient in an ercp [endoscopic retrograde cholangiopancreatography].Provider was going to insert stent in patient and when equipment was removed from packaging stent was detached.Unable to use.Equipment malfunction was noticed prior to proceeding.

• Brand Name: ADVANIX¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 21535689
• Report Number: 21535689
• Device Sequence Number: 7735896
• Product Code: FGE
• UDI-Device Identifier: 08714729787440
• UDI-Public: (01)08714729787440
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2025
• Report Date (Section F): 02/28/2025

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: M00534350
• Device Catalogue Number: M00534350
• Device Lot Number: 35403402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 119 KG
• Date Report Sent to FDA: 02/28/2025