MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WallFlex Biliary PLUS RX Stent System; Stents, Drains And Dilators For The Biliary Ducts

Model Number	M00547540
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Imdrf device code a0501 captures the reportable event of inner shaft/sheath detachment of device or device component.Imdrf impact code f2301 captures the reportable event of additional device required to remove the broken component of the catheter.Investigation summary: based on the available information, boston scientific concludes that the reported event of inner shaft/sheath detachment of component could be confirmed through review of the provided media evidence.The complaint device was not returned for evaluation as it was discarded; therefore, product analysis could not be performed.However, the documentation provided included images of the stent positioned within the anatomy of the patient and the stent after removal from the patient.Additionally, the image provided showed evidence of an inner sheath detachment.The investigation concluded the available information does not provide sufficient evidence to determine whether the confirmed inner shaft/sheath detachment was related to physician technique, procedural factors, device handling, or a potential device malfunction.For the reported event of delivery system difficult to remove, this event could not be confirmed, as the available media evidence did not provide sufficient information to evaluate device performance or substantiate the reported condition.Device history records 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 as it was discarded; therefore, product analysis could not be performed.However, the documentation provided included images of the stent and the inner sheath.Media inspection was performed on the provided photos, which it can be observed that the stent is positioned within the anatomy of the patient and also the stent after removal from the patient.Additionally, the photo provided evidence of an inner sheath detachment.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 bile duct to treat a tight stricture due to pancreatic head mass during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.The anatomy of the patient was torturous only in the proximal part and was not dilated prior to stent placement.During the procedure, resistance was encountered while advancing the catheter and deploying the stent before the stent was fully deployed.After the stent was fully deployed; the catheter became stuck on the stent as the physician began withdrawing the device from the scope.The technician attempted to re-sheath the catheter; however, this was unsuccessful.The catheter ultimately broke against the elevator, and the remaining plastic component was retrieved using biopsy forceps, which inadvertently pulled out the entire stent.The procedure was completed using a plastic stent.There are no patient complications reported as result of the procedure.

• Brand Name: WallFlex Biliary PLUS RX Stent System
• Common Device Name: Stents, Drains And Dilators For The Biliary Ducts
• 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 ; +1(914)571-6918
• MDR Report Key: 25829229
• Report Number: 3005099803-2026-02829
• Device Sequence Number: 9711632
• Product Code: FGE
• UDI-Device Identifier: 00191506044527
• UDI-Public: (01)00191506044527(17)280106(10)38271912
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K242950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: M00547540
• Device Catalogue Number: M00547540
• Device Lot Number: 0038271912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 01/06/2026
• 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