MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY PLUS RX STENT SYSTEM; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	M00547540
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx fully covered stent was to be implanted to treat a bile duct leak during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, the stent was too short.Another wallflex biliary rx fully covered stent was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0203 captures the reportable event of stent size incorrect.

• Brand Name: WALLFLEX BILIARY PLUS RX STENT SYSTEM
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25350651
• Report Number: 3005099803-2026-02242
• Device Sequence Number: 10311049
• Product Code: FGE
• UDI-Device Identifier: 00191506044527
• UDI-Public: (01)00191506044527(17)271128(10)38069847
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K242950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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 Model Number: M00547540
• Device Catalogue Number: M00547540
• Device Lot Number: 0038069847
• 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: 05/07/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 06/25/2026
• Date Device Manufactured: 11/28/2025
• 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 Age: 62 YR
• Patient Sex: Male