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

Model Number	M00570730
Medical Device Problem Codes	Premature Activation (1484); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted to treat a billiary stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, the guidewire was not able to be introduced in the stent.Reportedly, the stent prematurely deployed outside the patient.Another wallflex biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.Investigation summary: product analysis confirmed the reported event of device difficult to advance guidewire.Examination of the returned device identified a lifted gas ramp and misalignment of the inner shaft relative to the outer sheath.This condition likely interfered with proper guidewire tracking, preventing the guidewire from exiting at the gas ramp as intended.The observed damage is most consistent with device handling during guidewire insertion or possible rotation of the delivery system during the procedure.The additional reported event of stent premature deployment could not be confirmed through evaluation of the returned device.There is insufficient evidence to determine whether this event resulted from device manipulation during the procedure or a potential device malfunction.Device history record (dhr) review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: a wallflex biliary stent and delivery system was returned for analysis.Visual inspection confirmed the stent was received in a fully expanded and deployed condition.Functional evaluation was performed by reloading the device with a dreamwire 0.035 (lot 35594941, upn m00556160).During backloading, the guidewire did not exit through the gas ramp as expected.Inspection revealed the gas ramp was lifted, and the inner shaft was misaligned relative to the outer sheath, which likely contributed to the observed condition.Risk review: a risk review was completed and confirmed that the events of device difficult to advance guidewire and stent premature deployment were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted to treat a billiary stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, the guidewire was not able to be introduced in the stent.Reportedly, the stent prematurely deployed outside the patient.Another wallflex biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.

• 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: 24315623
• Report Number: 3005099803-2026-00561
• Device Sequence Number: 11971350
• Product Code: FGE
• UDI-Device Identifier: 08714729759324
• UDI-Public: (01)08714729759324(17)270828(10)37323427
• Combination Product (Y/N): N
• 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): 03/23/2026

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: M00570730
• Device Catalogue Number: M00570730
• Device Lot Number: 0037323427
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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