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

Model Number	M00570520
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of aborted/rescheduled procedure.
Event or Problem Description
It was reported to boston scientific that wallflex stent was to be implanted to treat a malignancy during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.Reportedly, the patient has a torturous anatomy.During procedure, it was reported that the stent is not fully deployed.When the stent was removed from the patient, it was partially deployed.The procedure was not completed.There were no patient complications reported as a result of the event.
Additional Manufacturer Narrative
Blocks b5 and h6 (impact code) have been updated with the additional information received on november 23,2025 and december 04, 2025.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex stent was to be implanted to treat cancer during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was dilated prior to stent placement.During procedure, it was reported that the stent is not fully deployed.When the stent was removed from the patient it was partially deployed.The procedure was not completed.There were no patient complications reported as a result of the event.Additional information received on november 23,2025 and december 04, 2025.It was reported that the physician completed the procedure on the same day the device was implanted using another of the same device.

• 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: 23535974
• Report Number: 3005099803-2025-06058
• Device Sequence Number: 18648589
• Product Code: FGE
• UDI-Device Identifier: 08714729764908
• UDI-Public: (01)08714729764908(17)270126(10)35711921
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: M00570520
• Device Catalogue Number: M00570520
• Device Lot Number: 0035711921
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/09/2025
• Date Device Manufactured: 01/26/2025
• 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