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

Model Number	M00570530
Medical Device Problem Codes	Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable investigation finding of stent failure to expand.Block h11: a wallflex biliary stent was received for analysis.Visual inspection determined that the stent was fully covered and in an undeployed condition.The outer sheath of the delivery system was observed to be bent.Procedural residue was present within the gas section and around the stent.Functional testing was performed by actuating the delivery system by sliding the handle back along the stainless-steel tube.Resistance was noted during actuation, and the stent exhibited an expansion anomaly.No additional issues were identified with the stent or delivery system.Product analysis confirmed the reported event of stent failure to deploy, as the device was returned fully covered and undeployed, and resistance with abnormal expansion was observed during functional testing.The presence of residue on the device likely interfered with normal stent expansion, contributing to the abnormal expansion observed during testing.In addition, procedural factors such as lesion characteristics, device handling, and technique used during the procedure (e.G., force applied) may have contributed to the bends observed on the outer sheath, which could have also impacted deployment performance.Based on the available information and investigation findings, the most probable cause of the reported event is adverse event related to procedure.
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 bile duct stenosis during a biliary stent implantation procedure performed on (b)(6) 2025.During the procedure, the stent could not be deployed.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.Note: this complaint has been deemed mdr reportable event based on the investigation result which revealed that stent failed to expand.Please see block h11 for the full investigation details.

• 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: 24345665
• Report Number: 3005099803-2026-00613
• Device Sequence Number: 9541280
• Product Code: FGE
• UDI-Device Identifier: 08714729764915
• UDI-Public: (01)08714729764915(17)270520(10)36566055
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 06/15/2026

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: M00570530
• Device Catalogue Number: M00570530
• Device Lot Number: 0036566055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 05/24/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 46 KG