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

Model Number	M00574710
Medical Device Problem Codes	Positioning Failure (1158); Nonstandard Device (1420); Material Integrity Problem (2978); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was not completed.The target lesion was located in the bile duct.An 8mmx80mm wallflex biliary transhepatic self-expanding stent was selected for treatment.However, strong resistance was encountered and it could not be moved midway at the start of deployment, preventing the stent from being released.The stent was fully recaptured upon removal, and although the stent was released outside the body, the flared tip section could not be re-retracted and protruded from the sheath tip.Consequently, the procedure was not completed due to this event.The physician believed that the damage occurred to the delivery tip when passing through a section of the bile duct exhibiting significant curvature.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, patient information, initial reporter, and product return status, but further information was unable to be obtained.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.
Event or Problem Description
It was reported that the procedure was not completed.The target lesion was located in the bile duct.An 8mmx80mm wallflex biliary transhepatic self-expanding stent was selected for treatment.However, strong resistance was encountered and it could not be moved midway at the start of deployment, preventing the stent from being released.The stent was fully recaptured upon removal, and although the stent was released outside the body, the flared tip section could not be re-retracted and protruded from the sheath tip.Consequently, the procedure was not completed due to this event.The physician believed that the damage occurred to the delivery tip when passing through a section of the bile duct exhibiting significant curvature.There were no patient complications as a result of this event.It was further reported that an attempt was made to retract the stent into the delivery outside the body; however, it could not be fully retracted and protruded from the tip part of the delivery catheter's outer sheath.

• Brand Name: WALLFLEX? BILIARY TRANSHEPATIC
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23148813
• Report Number: 2124215-2025-66313
• Device Sequence Number: 13246363
• Product Code: FGE
• UDI-Device Identifier: 08714729799399
• UDI-Public: (01)08714729799399(17)251204(10)32988323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112543
• 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,Followup
• Report Date (Section B): 11/18/2025

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 Expiration Date: 12/04/2025
• Device Model Number: M00574710
• Device Catalogue Number: M00574710
• Device Lot Number: 0032988323
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 11/18/2025
• Date Device Manufactured: 12/05/2023
• 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: Male