MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIFLEX? RX PUSHER; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00535010
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a advanix pancreatic stent was to be implanted next to the biliary papilla to treat jaundice during a biliary stone retrieval procedure performed on (b)(6) 2025.During the procedure, the stent was delivered through a duodenal scope with a working channel of 4.2mm.After the stent was pushed into the biliary papilla, it became stuck in the scope and could not be advanced further.After 15 minutes of attempting to maneuver the stent, they decided to pull it out.The stent was found to be slightly damaged, possibly due to the scope's elevator mechanism.Another wallflex enteral stent was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block b5 has been updated with the additional information received on june 30, 2025.Block h6 (device codes) has been corrected.Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be implanted to treat jaundice during a biliary stone retrieval procedure performed on (b)(6) 2025.During the procedure, the stent was delivered through a duodenal scope with a working channel of 4.2mm.After the stent was pushed into the biliary papilla, it became stuck in the scope and could not be advanced further.After 15 minutes of attempting to maneuver the stent, they decided to pull it out.The stent was found to be slightly damaged, possibly due to the scope's elevator mechanism.Another advanix pancreatic stent was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.

• Brand Name: NAVIFLEX? RX PUSHER
• 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: 22511575
• Report Number: 3005099803-2025-03259
• Device Sequence Number: 8788534
• Product Code: FGE
• UDI-Device Identifier: 08714729856214
• UDI-Public: (01)08714729856214(17)260109(10)34408290
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 07/23/2025

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: 01/09/2026
• Device Model Number: M00535010
• Device Catalogue Number: M00535010
• Device Lot Number: 0034408290
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 07/23/2025
• Date Device Manufactured: 07/10/2024
• 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