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

Model Number	M00570740
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
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 stent.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted into the common bile duct to treat a stricture caused by cancer during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was not dilated prior to stent placement.During procedure, the sheath had already fully retracted, and the stent was able to be deployed.However, the stent remained constrained, it failed to expand.The physician and nurses waited for two to three minutes but the stent remained constrained.The stent was then removed with the use of forceps, and the procedure was completed by using another wallflex biliary stent of a different length.There was no patient complications reported as a result of this event.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23648626
• Report Number: 3005099803-2025-06496
• Device Sequence Number: 9961347
• Product Code: FGE
• UDI-Device Identifier: 08714729759331
• UDI-Public: (01)08714729759331(17)260813(10)34631279
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: 08/13/2026
• Device Model Number: M00570740
• Device Catalogue Number: M00570740
• Device Lot Number: 0034631279
• 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: 10/30/2025
• Initial Report FDA Received Date: 11/25/2025
• Date Device Manufactured: 08/13/2024
• 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