MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY; BILIARY STENT SYSTEM FOR BENIGN STRICTURES

Model Number	M00570370
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary was implanted to treat bile duct stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the preparation, when the staff opened the package, the tip was bent, and the stent was partially deployed.The procedure was completed with another with another same of device.There was no patient complication reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a04 is being used to capture the reportable event of tip damaged/defective.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary was implanted to treat bile duct stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the preparation, when the staff opened the package, the tip was bent, and the stent was partially deployed.The procedure was completed with another with another same of device.There was no patient complication reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a04 is being used to capture the reportable event of tip damaged/defective.Block h11: a wallflex biliary stent was returned to for analysis with the stent fully covered and undeployed.Functional inspection was performed by deploying the stent without any issues or resistance.Additionally, the tip of the device was inspected, and no damages were found.Based on the available information, there is not enough information to confirm the reported event of stent partially deployed; therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: BILIARY STENT SYSTEM FOR BENIGN STRICTURES
• 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: 21625507
• Report Number: 3005099803-2025-01026
• Device Sequence Number: 12895644
• Product Code: PNB
• UDI-Device Identifier: 08714729953180
• UDI-Public: 08714729953180
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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 Model Number: M00570370
• Device Catalogue Number: M00570370
• Device Lot Number: 0035410371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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