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

Model Number	M00537010
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of pancreatic stent kinked.
Event or Problem Description
It was reported to boston scientific corporation that a advanix pancreatic stent was to be implanted during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2025.During the procedure, the stent was bent.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a advanix pancreatic stent was to be implanted during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2025.During the procedure, the stent was bent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of pancreatic stent kinked.Block h11: an advanix pancreatic stent was returned for analysis.Visual and microscopic inspection of the returned device identified multiple areas with bents and kinks along the stent.Additionally, media inspection of a photograph provided by the complainant also identified that the stent appeared bent/kinked.Product analysis confirmed the reported event of stent kinked.The investigation concluded that the reported event was 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? PANCREATIC STENT
• 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: 22918629
• Report Number: 3005099803-2025-04274
• Device Sequence Number: 15918812
• Product Code: FGE
• UDI-Device Identifier: 08714729856726
• UDI-Public: (01)08714729856726(17)261009(10)36265530
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133700
• 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
• Report Date (Section B): 11/17/2025

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: M00537010
• Device Catalogue Number: M00537010
• Device Lot Number: 0036265530
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2025
• 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
• Patient Sex: Unknown