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

Model Number	M00537260
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code captures the reportable event of stent break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent pigtail leading barb 7f 7cm was to be implanted in the pancreatic duct during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2025.During the procedure, the pigtail part of the stent was broken, preventing the orange pusher part from advancing despite being pushed.A different device was used to complete the procedure.There were no patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent pigtail leading barb 7f 7cm was to be implanted in the pancreatic duct during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2025.During the procedure, the pigtail part of the stent was broken, preventing the orange pusher part from advancing despite being pushed.A different device was used to complete the procedure.There were no patient complications as a result of this event.Additional information received on july 17, 2025.The reported complaint occurred outside the body, prior to device insertion.
Additional Manufacturer Narrative
Block h6: imdrf device code captures the reportable event of stent break.Block h11: an advanix pancreatic stent was returned for analysis; the delivery system was not returned.Visual examination of the returned device found that the pigtail part of the stent was broken.No other problems were noted with the stent.Product analysis confirmed the reported event of stent broken.On the other hand, the reported event of stent flap cover difficult to advance was not confirmed as it happened during the procedure and it was not possible replicate it in the laboratory.It was reported that during the procedure, "the pigtail part of the stent was broken, preventing the orange pusher part from advancing despite being pushed." it most likely, procedural factors could have affected the overall performance of the device.Therefore, the most probable root cause is adverse event related to the 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22465000
• Report Number: 3005099803-2025-03167
• Device Sequence Number: 7986078
• Product Code: FGE
• UDI-Device Identifier: 08714729856856
• UDI-Public: (01)08714729856856(17)260718(10)35645950
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/06/2025

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: 07/18/2026
• Device Model Number: M00537260
• Device Catalogue Number: M00537260
• Device Lot Number: 0035645950
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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