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

Model Number	M00537010
Medical Device Problem Codes	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	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be implanted during an unspecified procedure performed on (b)(6) 2025.During the procedure, it was not possible for the stent to be set on the implanting guidewire because the pigtail tip was kinked.The procedure was completed using another of the same device.There was no patient complications reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent kinked.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent kinked.Block h11: an advanix pancreatic stent was returned for analysis.Visual inspection could not evidence damages.However, under microscope inspection the stent was observed kinked, and two of the stent holes were observed damaged.Product analysis confirmed the reported event of stent kink.During microscopic inspection it was observed that the stent was kinked and two of the stent holes were damaged.The investigation concluded that the reported event and additional observed damages were most likely caused by procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).Taking all available information into consideration, the investigation concluded that the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be implanted during an unspecified procedure performed on (b)(6) 2025.During the procedure, it was not possible for the stent to be set on the implanting guidewire because the pigtail tip was kinked.The procedure was completed using another of the same device.There was no patient complications reported as a result of the event.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22319634
• Report Number: 3005099803-2025-02865
• Device Sequence Number: 8857577
• Product Code: FGE
• UDI-Device Identifier: 08714729856726
• UDI-Public: (01)08714729856726(17)260125(10)34516358
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: 01/25/2026
• Device Model Number: M00537010
• Device Catalogue Number: M00537010
• Device Lot Number: 0034516358
• 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: 06/01/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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