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

Model Number	M00534320
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.Imdrf impact code f2301 captures the use of additional devices to retrieve the broken pieces.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was to be implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the device was unable to deploy properly as the stent introducer began to shear.The stent system and all pieces were removed, and the procedure was successfully completed using another device of the same model.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks a1 (patient identifier), a2 (date of birth), a3a (sex), a3b (gender), a4 (weight and unit of measure - weight), and b5 (describe event or problem) were updated based on the additional information received on august 21, 2025.Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.Imdrf impact code f2301 captures the use of additional devices to retrieve the broken pieces.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was to be implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the device was unable to deploy properly as the stent introducer began to shear.The stent system and all pieces were removed, and the procedure was successfully completed using another device of the same model.There were no patient complications reported as a result of this event.***additional information received on august 21, 2025*** it was reported that the advanix biliary stent was to be implanted in the common bile duct to treat a potential leak.During procedure, the guide catheter broke and was removed using a snare.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex delivery system was to be implanted in the common bile duct to treat a potential leak during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the device was unable to deploy properly as the stent introducer began to shear.The stent system and all pieces were removed with the use of a snare, and the procedure was successfully completed using another device of the same model.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.Imdrf impact code f2301 captures the use of the additional device used (snare) to retrieve the broken fragments.Block h11: the advanix stent and guide catheter were returned for analysis; the remaining parts of the delivery system were not.A microscopic examination observed that the stent suture hole was torn.No other damages were noted on the advanix stent or guide catheter.Product analysis confirmed the reported event of stent failure to deploy and catheter guide break.The investigation concluded that the reported event and additional observed damage were most likely caused by procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22745694
• Report Number: 3005099803-2025-03819
• Device Sequence Number: 21075772
• Product Code: FGE
• UDI-Device Identifier: 08714729787419
• UDI-Public: (01)08714729787419(17)270421(10)36509519
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• 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,Followup
• Report Date (Section B): 10/25/2025

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 Model Number: M00534320
• Device Catalogue Number: M00534320
• Device Lot Number: 0036509519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 08/21/2025; 10/02/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/16/2025; 10/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 109 KG