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

Model Number	M00537260
Medical Device Problem Codes	Use of Device Problem (1670); 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	08/05/2025
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 to treat a stricture in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, an attempt was made to advance the stent over the guidewire.Upon reaching the ampulla, it was observed that the distal portion of the stent, specifically beneath the leading barb, appeared kinked.Another advanix pancreatic stent was used to complete the procedure.There were no patient complications reported as a result of this event.It was reported that the guidewire was in the pancreatic duct, during the attempted deployment.Per the instruction for use, "if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed." additional information received on august 15, 2025.It was reported that there was a 10-minute delay in the procedure.
Additional Manufacturer Narrative
Block h6 (impact code) has been corrected.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 to treat a stricture in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, an attempt was made to advance the stent over the guidewire.Upon reaching the ampulla, it was observed that the distal portion of the stent, specifically beneath the leading barb, appeared kinked.Another advanix pancreatic stent was used to complete the procedure.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was in the pancreatic duct, during the attempted deployment.Per the instruction for use, "if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed." additional information received on august 15, 2025 it was reported that there was a 10-minute delay in the procedure.
Event or Problem Description
It was reported to boston scientific corporation that a advanix pancreatic stent was to be implanted to treat a stricture in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, an attempt was made to advance the stent over the guidewire.Upon reaching the ampulla, it was observed that the distal portion of the stent, specifically beneath the leading barb, appeared kinked.Another advanix pancreatic stent was used to complete the procedure.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was in the pancreatic duct, during the attempted deployment.Per the instruction for use, "if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed.".Additional information received on august 15, 2025: it was reported that there was a 10-minute delay in the procedure.
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.A visual examination of the returned device revealed that the stent was kinked and torn.Microscopic examination was performed, confirming the presence of tearing and deformation on the stent structure.No other damages were noted to the stent and delivery system.Product analysis: confirmed the reported event of stent kinked.Taking all available information into consideration, the investigation concluded that the reported event and observed damage were most likely procedural factors as handling of the device and the technique used by the physician could have resulted in the damages encountered in the device during stent insertion.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: 22907075
• Report Number: 3005099803-2025-04271
• Device Sequence Number: 21036242
• Product Code: FGE
• UDI-Device Identifier: 08714729856856
• UDI-Public: (01)08714729856856(17)260319(10)34869438
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2025

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 Expiration Date: 03/19/2026
• Device Model Number: M00537260
• Device Catalogue Number: M00537260
• Device Lot Number: 0034869438
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 09/01/2025; 11/18/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/25/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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 Sex: Unknown