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

Model Number	M00532190
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1 (initial reporter facility name): the initial reporter facility name is (b)(6).Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was to be implanted in the common bile duct to treat gallstones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.Prior to the procedure, upon opening the package and outside the patient, the sheath was observed to be abnormally kinked.The physician applied minimal force, which resulted in immediate damage to the product.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1 (initial reporter facility name): the initial reporter facility name is the (b)(6).Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: the advanix biliary stent was not returned for evaluation.Therefore, product analysis could not be performed.However, the documentation provided includes photographs of the stent.A media analysis was performed where it can be observed that the stent damaged.Media analysis could not confirm the reported event of catheter guide break and catheter guide kinked.Based on the available information (and in the absence of device return), the root cause of the reported clinical observations cannot be established.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was to be implanted in the common bile duct to treat gallstones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.Prior to the procedure, upon opening the package and outside the patient, the sheath was observed to be abnormally kinked.The physician applied minimal force, which resulted in immediate damage to the product.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was to be implanted in the common bile duct to treat gallstones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.Prior to the procedure, upon opening the package and outside the patient, the sheath was observed to be abnormally kinked.The physician applied minimal force, which resulted in immediate damage to the product.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1 (initial reporter facility name): the initial reporter facility name is (b)(6).Block h6 device code has been corrected.Block h6: imdrf device code a0406 captures the reportable event of stent kinked.Block h11: the advanix biliary stent was not returned for evaluation.Therefore, product analysis could not be performed.However, the documentation provided includes photographs of the stent.A media analysis was performed where it can be observed that the stent damaged and kinked.Media analysis could confirm the reported event of stent kinked as it was observed on the photo wherein the stent is damaged and kinked.However, without proper evaluation of the device it remains unknown the most probable causes that contributed to the event.There is not enough evidence to determine if the reported event was related to the device manipulation of the physician during the procedure or related to a device malfunction.Taking all available information into consideration, the most probable cause of the reported event is cause not established.

• 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: 22580866
• Report Number: 3005099803-2025-03525
• Device Sequence Number: 7082504
• Product Code: FGE
• UDI-Device Identifier: 08714729786986
• UDI-Public: (01)08714729786986(17)261023(10)35130054
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2026

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: M00532190
• Device Catalogue Number: M00532190
• Device Lot Number: 0035130054
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 08/01/2025; 12/26/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/20/2025; 01/20/2026
• Date Device Manufactured: 10/23/2024
• 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
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 51 KG