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

Model Number	M00534340
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the additional device used to remove the broken guide catheter inside the patient.
Event or Problem Description
It was reported to boston scientific corporation that a advanix- naviflex rx biliary stent was to be implanted in the bile duct/ ampulla to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent was attempted to be deployed; however, the stent would not fully deploy, and the guide catheter broke off.A grasping forceps was used to remove the broken guide catheter.The procedure was completed using the original stent.There were no patient complications as a result of this event.Note: a photo of the complaint device was provided by the complainant, showing that the guide catheter was detached and kinked, and the pull wire bent.
Event or Problem Description
It was reported to boston scientific corporation that a advanix- naviflex rx biliary stent was to be implanted in the bile duct/ ampulla to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent was attempted to be deployed; however, the stent would not fully deploy, and the guide catheter broke off.A grasping forceps was used to remove the broken guide catheter.The procedure was completed using the original stent.There were no patient complications as a result of this event.Note: a photo of the complaint device was provided by the complainant, showing that the guide catheter was detached and kinked, and the pull wire bent.Additional information received on december 10, 2024.It was reported that the stent was deployed, but during removal of the delivery system, the guide catheter broke off and had to be removed using grasping forceps.
Additional Manufacturer Narrative
Block b5 has been updated with the additional information received on december 10, 2024.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the additional device used to remove the broken guide catheter inside the patient.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20897699
• Report Number: 3005099803-2024-06287
• Device Sequence Number: 9053742
• Product Code: FGE
• UDI-Device Identifier: 08714729787433
• UDI-Public: 08714729787433
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 01/09/2025

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 Expiration Date: 01/22/2026
• Device Model Number: M00534340
• Device Catalogue Number: M00534340
• Device Lot Number: 0033269908
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/09/2025
• Date Device Manufactured: 01/23/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown