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

Model Number	M00536910
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
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 in pancreas during the endoscopic retrograde pancreatic drainage(erpd) procedure performed on (b)(6) 2025.During the procedure, the distal tip part was bent.There was no patient complications were reported as a result of this event.The patient's condition was good.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of material deformation.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was implanted in pancreas during the endoscopic retrograde pancreatic drainage (erpd) procedure performed on (b)(6) 2025.During the procedure, the distal tip part was bent.The procedure was completed with the original device.There was no patient complications were reported as a result of this event.The patient's condition was good.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of material deformation.

• 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: 22004765
• Report Number: 3005099803-2025-02133
• Device Sequence Number: 9099767
• Product Code: FGE
• UDI-Device Identifier: 08714729856504
• UDI-Public: (01)08714729856504(17)250807(10)33369338
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: 08/07/2025
• Device Model Number: M00536910
• Device Catalogue Number: M00536910
• Device Lot Number: 0033369338
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2024
• 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