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

Model Number	M00570890
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of stent prematurely deployed.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was used during a procedure performed on an unknown date.It was reported that while preparing a 10mm x 40mm wallflex biliary uncovered stent for placement, the stent unintentionally deployed during removal of the inner sheath prior to being handed to the physician.The device was rendered unusable and was not deployed inside the patient.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of stent prematurely deployed.Investigation results based on the available information, boston scientific corporation confirmed the reported event of stent premature deployment.Device history record 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 was returned for analysis.A visual examination of the returned device revealed that the device was returned without the stent, with the shipping mandrel present inside the device.No other damage was noted to the stent or the delivery system.Labeling review: a labeling review was performed.Based on the available information, the device was used in a manner inconsistent with the instructions for use (ifu).The ifu clearly states: by inserting the trailing end of the guidewire, the shipping mandrel will be pushed out.Do not remove the shipping mandrel before loading the guidewire.However, the device returned with the shipping mandrel inside.The ifu contains detailed device information and instructions for the device use and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.Risk review: a review of the wallflex biliary stent was completed and confirmed that the event of stent premature deployment.These events type 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 failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was used during a procedure performed on an unknown date.It was reported that while preparing a 10mm x 40mm wallflex biliary uncovered stent for placement, the stent unintentionally deployed during removal of the inner sheath prior to being handed to the physician.The device was rendered unusable and was not deployed inside the patient.There were no patient complications 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: 23999651
• Report Number: 3005099803-2026-00093
• Device Sequence Number: 10222596
• Product Code: FGE
• UDI-Device Identifier: 08714729765332
• UDI-Public: (01)08714729765332(17)261216(10)35497589
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: M00570890
• Device Catalogue Number: M00570890
• Device Lot Number: 0035497589
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 03/01/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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