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

Model Number	M00570530
Medical Device Problem Codes	Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code f2301 captures the additional device required to remove the stent.Block e1: initial reporter's address: (b)(6).
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 during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, a radiologist used the previously established percutaneous transhepatic cholangiographic drainage pathway from the right intrahepatic duct of the liver to place the metal stent.During deployment, the delivery system became slightly stuck, preventing the stent from fully deploying.In an attempt to reposition and facilitate deployment, the physician manipulated the stent back and forth.This maneuver inadvertently caused the stent to migrate entirely into the common bile duct.The proximal opening of the stent was not aligned with the papilla, compromising its intended function.The procedure was completed using another of the same device.There were no patient complications reported as a result of the procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was implanted into the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on december 26, 2025.During the procedure, a radiologist used the previously established percutaneous transhepatic cholangiographic drainage pathway from the right intrahepatic duct of the liver to place the metal stent.During deployment, the delivery system became slightly stuck, preventing the stent from fully deploying.In an attempt to reposition and facilitate deployment, the physician manipulated the stent back and forth.This maneuver inadvertently caused the stent to migrate entirely into the common bile duct.The proximal opening of the stent was not aligned with the papilla, compromising its intended function.The stent remains implanted, and the procedure was completed using another of the same device.There were no patient complications reported as a result of the procedure.Additional information received on january 25, 2026.It was reported that the anatomy of the patient was torturous and the anatomy of the patient was not dilated.The size of the lesion was observed to be smaller than what was anticipated.
Additional Manufacturer Narrative
Block b5 has been corrected and updated based on additional information received on january 25, 2026.Block h6 (impact codes) has been corrected.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Block e1: initial reporter's address:(b)(6); reported here as it exceeded the character limit for the designated field.

• 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: 24130739
• Report Number: 3005099803-2026-00246
• Device Sequence Number: 10344248
• Product Code: FGE
• UDI-Device Identifier: 08714729764915
• UDI-Public: (01)08714729764915(17)270827(10)37310169
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 02/19/2026

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 Model Number: M00570530
• Device Catalogue Number: M00570530
• Device Lot Number: 0037310169
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 01/25/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/19/2026
• Date Device Manufactured: 08/27/2025
• 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 Sex: Unknown