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

Model Number	M00570520
Medical Device Problem Codes	Use of Device Problem (1670); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code f2301 captures the event of the additional device required (forceps) to remove the stent.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted into the bile duct to treat a benign biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.The anatomy of the patient was tortuous and was dilated prior to the placement of the stent.During the procedure, resistance was encountered during the deployment.After the stent was fully deployed, it was found to be positioned in an undesired location.Due to this, the stent was removed from the patient using forceps.The procedure was completed using a different device.There was no patient complications reported as a result of this event.Note: it was reported that the wallflex biliary stent was used to treat a benign stricture.However, per the wallflex biliary rx covered stent system instructions for use (ifu), the stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.The device is not indicated to be used for the treatment of benign strictures.
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code f2301 captures the event of the additional device required (forceps) to remove the stent.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of stent positioning issue.The device has not been returned for product evaluation as the device was disposed; therefore, a technical analysis could not be performed.It was noted that the device was used in a manner inconsistent with the ifu (instructions for use) / product label as the complainant reported that the device was intended to be placed on the common bile duct to treat benign biliary stricture.The ifu states, "the stent is intended for palliative treatment of biliary strictures caused by malignant tumors, relief of malignant biliary obstruction prior to surgery." the stent is not intended for treatment of benign biliary stricture.Based on the information available and without proper evaluation of the device, it is unknown if the reported events were due to the physician's technique during the procedure, or whether it was related to a 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.Risk review: a risk review was completed and confirmed that the event of stent positioning 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 unable to exclude device problem.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted into the bile duct to treat a benign biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.The anatomy of the patient was tortuous and was dilated prior to the placement of the stent.During the procedure, resistance was encountered during the deployment.After the stent was fully deployed, it was found to be positioned in an undesired location.Due to this, the stent was removed from the patient using forceps.The procedure was completed using a different device.There was no patient complications reported as a result of this event.Note: it was reported that the wallflex biliary stent was used to treat a benign stricture.However, per the wallflex biliary rx covered stent system instructions for use (ifu), the stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.The device is not indicated to be used for the treatment of benign strictures.

• 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: 24514519
• Report Number: 3005099803-2026-00831
• Device Sequence Number: 18578398
• Product Code: FGE
• UDI-Device Identifier: 08714729764908
• UDI-Public: (01)08714729764908(17)270520(10)36558008
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: M00570520
• Device Catalogue Number: M00570520
• Device Lot Number: 0036558008
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/01/2026
• Date Device Manufactured: 05/20/2025
• 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