MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX? BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00570540
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx covered stent was to be implanted in the bile duct to treat a biliary stricture during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2025.During the procedure, the stent did not fully expand when deployed inside the patient.The stent was removed from the patient and the procedure was completed with another wallflex biliary stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf impact code f2301 captures the reportable event of additional device required to remove the unexpanded stent.

• Brand Name: WALLFLEX? BILIARY
• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22484344
• Report Number: 3005099803-2025-03293
• Device Sequence Number: 18310042
• Product Code: FGE
• UDI-Device Identifier: 08714729764922
• UDI-Public: (01)08714729764922(17)260529(10)34126459
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K140630
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2026
• Device Model Number: M00570540
• Device Catalogue Number: M00570540
• Device Lot Number: 0034126459
• 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: 06/16/2025
• Initial Report FDA Received Date: 07/11/2025
• Date Device Manufactured: 05/29/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown