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

Model Number	M00570660
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0406captures the reportable event of stent material deformation.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of stent material deformation.The device has not been returned for product evaluation; therefore, a technical analysis could not be performed.Without proper evaluation of the device, it is unknown if the reported event was due to the technique used during the procedure, anatomical conditions or related to device malfunction.Device history review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: the complaint device was not returned for evaluation; therefore, a technical analysis could not be performed.Media analysis was performed on a provided picture by the complainant, and it can be observed the original pouch of the product with the respective label including upn and lot involved.Risk review: a risk review was completed and confirmed that the events of stent material deformation were defined in the risk documentation.This event type has 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 cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was attempted to be implanted to the common bile duct to treat a biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During procedure, in the attempt to deploy the stent, the stent was kinked and malfunctioned.The procedure was completed using a non-boston scientific device.There was no patient complications reported as a result of the procedure.

• 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: 25303099
• Report Number: 3005099803-2026-02155
• Device Sequence Number: 13141056
• Product Code: FGE
• UDI-Device Identifier: 08714729759287
• UDI-Public: (01)08714729759287(17)270402(10)36208750
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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: M00570660
• Device Catalogue Number: M00570660
• Device Lot Number: 0036208750
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 06/25/2026
• Date Device Manufactured: 04/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown